[Federal Register Volume 72, Number 180 (Tuesday, September 18, 2007)]
[Rules and Regulations]
[Pages 53314-53379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-4595]



[[Page 53313]]

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Part III





Department of Agriculture





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Animal and Plant Health Inspection Service



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9 CFR Parts 93, 94, 95, and 96



Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of 
Live Bovines and Products Derived From Bovines; Final Rule

  Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / 
Rules and Regulations  

[[Page 53314]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, 95, and 96

[Docket No. APHIS-2006-0041]
RIN 0579-AC01


Bovine Spongiform Encephalopathy; Minimal-Risk Regions; 
Importation of Live Bovines and Products Derived From Bovines

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations regarding the importation of 
animals and animal products to establish conditions for the importation 
of the following commodities from regions that present a minimal risk 
of introducing bovine spongiform encephalopathy into the United States: 
Live bovines for any use born on or after a date determined by the 
Animal and Plant Health Inspection Service to be the date of effective 
enforcement of a ruminant-to-ruminant feed ban in the region of export; 
blood and blood products derived from bovines; and casings and part of 
the small intestine derived from bovines. We are making these 
amendments after conducting a risk assessment and comprehensive 
evaluation of the issues and concluding that such bovines and bovine 
products can be safely imported under the conditions described in this 
rule. This document also removes the delay in applicability of certain 
provisions of a final rule published in January 2005.

DATES: Effective Date: November 19, 2007.

FOR FURTHER INFORMATION CONTACT: For information regarding ruminant 
products, contact Dr. Karen James-Preston, Director, Technical Trade 
Services, Animal Products, National Center for Import and Export, VS, 
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.
    For information concerning live ruminants, contact Dr. Lee Ann 
Thomas, Director, Technical Trade Services, Animals, Organisms and 
Vectors, and Select Agents, National Center for Import and Export, VS, 
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4935.
    For other information concerning this proposed rule, contact Dr. 
Lisa Ferguson, Senior Staff Veterinarian, National Center for Animal 
Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 
20737-1231; (301) 734-6954.

SUPPLEMENTARY INFORMATION:

Purpose

    This document makes final a proposed rule that the Animal and Plant 
Health Inspection Service (APHIS) of the U.S. Department of Agriculture 
(USDA or the Department) published in the Federal Register on January 
9, 2007 (72 FR 1101-1129, Docket No. APHIS-2006-0041). Additionally, it 
removes the delay of applicability of certain provisions of a final 
rule APHIS published in January 2005. The removal of delay is discussed 
below under the heading ``Removal of Partial Delay of Applicability of 
Provisions of January 2005 Final Rule.''
    In our January 2007 proposed rule, we proposed to amend the 
regulations in 9 CFR parts 93, 94, 95, and 96 to establish conditions 
for the importation of the following commodities from regions that 
present a minimal risk of introducing bovine spongiform encephalopathy 
(BSE) into the United States: Live bovines for any use born on or after 
a date determined by APHIS to be the date of effective enforcement of a 
ruminant-to-ruminant feed ban in the region of export; blood and blood 
products derived from bovines; and casings and part of the small 
intestine derived from bovines.
    In this document, we respond to public comments received on the 
proposed rule and its underlying risk assessment and other supporting 
analyses. Additionally, we discuss below the history of APHIS 
rulemaking related to BSE minimal-risk regions.

Background

    APHIS regulates the importation of animals and animal products into 
the United States to guard against the introduction of animal diseases. 
The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to below as 
the regulations) govern the importation of certain animals, birds, 
poultry, meat, other animal products and byproducts, hay, and straw 
into the United States in order to prevent the introduction of various 
animal diseases, including BSE, a chronic degenerative disease 
affecting the central nervous system of cattle.
    With some exceptions, APHIS' regulations prohibit or restrict the 
importation of live ruminants and certain ruminant products and 
byproducts from the following three categories of regions with regard 
to BSE: (1) Those regions in which BSE is known to exist (listed in 
Sec.  94.18(a)(1) of the regulations); (2) those regions that present 
an undue risk of introducing BSE into the United States because their 
import requirements are less restrictive than those that would be 
acceptable for import into the United States and/or because the regions 
have inadequate surveillance (listed in Sec.  94.18(a)(2) of the 
regulations); and (3) those regions that present a minimal risk of 
introducing BSE into the United States via live ruminants and ruminant 
products and byproducts (listed in Sec.  94.18(a)(3) of the 
regulations).

Chronology of Federal Register Publications Regarding BSE Minimal-Risk 
Regions

    We added the Sec.  94.18(a)(3) category (BSE minimal-risk regions) 
to the regulations in a final rule published in the Federal Register on 
January 4, 2005 (70 FR 459-553, Docket No. 03-080-3). In the final 
rule, we specified which commodities may be imported from BSE minimal-
risk regions and under what conditions, and recognized Canada as a BSE 
minimal-risk region. (At this time, Canada is the only recognized BSE 
minimal-risk region.)
    The January 2005 final rule was based on a proposed rule we 
published in the Federal Register on November 4, 2003 (68 FR 62386-
62405, Docket No. 03-080-1). On December 25, 2003, less than 2 weeks 
before the close of the comment period for our proposed rule, a case of 
BSE in a dairy cow of Canadian origin in Washington State was verified 
by an international reference laboratory.
    In response to comments from the public requesting an extension of 
the comment period and in order to give the public an additional 
opportunity to comment on the proposed rule in light of this 
development, on March 8, 2004, we published a document in the Federal 
Register (69 FR 10633-10636, Docket No. 03-080-2) reopening the comment 
period.
    On January 4, 2005, along with the final rule, we published in the 
Federal Register a notice (70 FR 554, Docket No. 03-080-4) announcing 
the availability of, and requesting comments on, a final environmental 
assessment (EA) regarding the potential impact on the quality of the 
human environment due to the importation of ruminants and ruminant 
products and byproducts from Canada under the conditions specified in 
the final rule. On January 21, 2005, we published in the Federal 
Register a notice (70 FR 3183-3184, Docket No. 03-080-5) announcing the 
availability of a corrected version of the EA for public review and 
comment. On April 8, 2005, we published in the Federal Register a 
finding (70 FR 18252-18262, Docket No. 03-080-7) that the provisions of 
the final rule would not

[[Page 53315]]

have a significant impact on the quality of the human environment.
    On March 11, 2005, we published a document in the Federal Register 
that gave notice that the Secretary of Agriculture was delaying until 
further notice the implementation of certain provisions of the final 
rule with regard to certain commodities (70 FR 12112-12113, Docket No. 
03-080-6).
    On November 28, 2005, we published in the Federal Register an 
interim rule (70 FR 71213-71218, Docket No. 03-080-8) that amended 
certain provisions established by the January 2005 final rule. The 
interim rule broadened the list of who is authorized to break seals on 
conveyances and allows transloading under supervision of products 
transiting the United States.
    On March 14, 2006, we published in the Federal Register a technical 
amendment (71 FR 12994-12998, Docket No. 03-080-9) that clarified our 
intent with regard to certain provisions in the January 2005 final rule 
and corrected several inconsistencies within the rule.
    On August 9, 2006, we published in the Federal Register a proposed 
rule (71 FR 45439-45444, Docket No. APHIS-2006-0026) that proposed to 
amend the provisions established by the January 2005 final rule by 
removing several restrictions regarding the identification of animals 
and the processing of ruminant materials from BSE minimal-risk regions, 
and by relieving BSE-based restrictions on hide-derived gelatin from 
BSE minimal-risk regions. We solicited comments concerning our proposal 
for 60 days ending October 10, 2006. On November 9, 2006, we published 
a document in the Federal Register (71 FR 65758-65759, Docket No. 
APHIS-2006-0026) reopening and extended the comment period until 
November 24, 2006. We received a total of 10 comments by that date. We 
are considering the issues raised by the commenters and will address 
them in a separate rulemaking document.

Scope of the January 2005 Final Rule

    The regulations established by the January 2005 final rule and 
subsequent amendments have allowed the importation from BSE minimal-
risk regions of live bovines that are under 30 months of age when 
imported and when slaughtered and that have been subject to a ruminant 
feed ban equivalent to that in place in the United States.
    We did not attempt, for that rulemaking, to assess the BSE risk 
associated with the importation of live bovines 30 months of age or 
older from a BSE minimal-risk region. Our March 8, 2004, document that 
reopened the comment period on the November 2003 proposed rule stated 
that APHIS was evaluating the appropriate approach with regard to the 
importation of live animals 30 months of age or older from BSE minimal-
risk regions, and would address that issue in a supplemental rulemaking 
proposal in the Federal Register. The provisions in our January 9, 
2007, proposed rule regarding live bovines were the result of that 
evaluation.
    The regulations established by the January 2005 final rule also 
provided for the importation of the following commodities derived from 
bovines of any age: (1) Meat, meat food products, and meat byproducts; 
(2) whole or half carcasses; (3) offal; (4) tallow composed of less 
than 0.15 percent insoluble impurities that are not otherwise eligible 
for importation under Sec.  95.4(a)(1)(i) of the regulations; and (5) 
gelatin derived from bones of bovines that is not otherwise eligible 
for importation under Sec.  94.18(c) of the regulations.
    The January 2005 final rule and subsequent amendments did not 
change the regulations concerning the importation of blood and blood 
products from regions listed in Sec.  94.18(a); the requirements for 
the importation of blood and blood products from BSE minimal-risk 
regions remain the same as the requirements for importation of blood 
and blood products from other regions listed in Sec.  94.18(a)--only 
serum and serum albumin have been eligible for importation. The January 
2005 final rule also did not change the regulations concerning the 
importation of bovine casings (defined as intestines, stomachs, 
esophagi, and urinary bladders) from regions listed in Sec.  94.18(a); 
the requirements for the importation of bovine casings from BSE 
minimal-risk regions remain the same as the requirements for 
importation of bovine casings from other regions listed in Sec.  
94.18(a)--only bovine stomachs are eligible for importation.
    The January 2005 final rule and subsequent amendments allowed trade 
to resume in many, but not all, of the commodities that had been 
prohibited importation from Canada following detection of a BSE-
infected cow in Canada in May 2003. Following our January 2005 final 
rule, we continued to consider the BSE risk associated with older 
bovines and other bovine products from BSE minimal-risk regions--and 
Canada in particular--including bovine blood and blood products, bovine 
small intestine other than the distal ileum, and bovine casings, and 
included provisions in our January 2007 proposed rule for the 
importation of those commodities.\1\
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    \1\ The regulations regarding BSE minimal-risk regions apply to 
bison as well as cattle. In Sec. Sec.  93.400, 94.0, and 95.1 of the 
regulations, bovine is defined as Bos taurus, Bos indicus, and Bison 
bison. Although the research and other data cited in this rulemaking 
refer to bovines other than bison (i.e., to ``cattle''), there is no 
evidence to indicate that the BSE susceptibility of bison differs 
from that of cattle. We therefore assume that our conclusions based 
on cattle-specific evidence discussed in this rulemaking are also 
applicable to bison. Given that no cases of BSE have been detected 
in bison, this is likely a conservative assumption. The provisions 
of this rule apply to bovines as defined in the regulations, which 
include bison.
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Peer Review of APHIS' Risk Assessment

    As part of this rulemaking, APHIS conducted an assessment that 
evaluated the animal health risk to the United States of BSE--i.e., the 
likelihood of establishment and the potential impacts of cases that may 
occur even without establishment--as a result of importing the bovine 
commodities considered in this rule (APHIS 2006b). Our assessment 
concluded that, over the 20 years of the analysis, the BSE risk to the 
United States is negligible. We made the risk assessment available for 
public review and comment at the time the proposed rule was published.
    In addition to making the risk assessment available for review and 
comment by the general public, we requested an external, formal, 
independent peer review of the assessment by recognized experts in the 
field, consistent with guidelines of the U.S. Office of Management and 
Budget (OMB 2004). The objective of the peer review was to determine 
whether the risk assessment was scientifically sound, transparent, and 
consistent with international standards (e.g., those by the OIE); the 
application of external assessments or models was appropriate; and the 
assumptions were justified, supported and reasonable. Comments 
submitted by the public on the proposed rule were submitted to the peer 
reviewers for their consideration. The peer review process was 
coordinated by an independent private contractor.
    The full peer review report may be viewed at http://www.aphis.usda.gov/peer_review/peer_review_agenda.shtml. 
Additionally, we have included below, under the heading ``Final Report 
from Peer Review of APHIS' Risk Assessment and Responses to Peer 
Reviewer Questions and Recommendations,'' APHIS' responses to reviewer 
comments that we consider representative of the content-related 
questions and recommendations of the report, and our response to those 
questions and recommendations. In summary, the

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reviewers found that the methods used in the risk assessment were 
scientifically rigorous in terms of using existing literature and 
models appropriately and making sound assumptions and that the risk 
assessment itself adhered to international risk assessment standards. 
The reviewers also agreed with the conclusion that the likelihood of 
establishment of BSE in the U.S. cattle population is negligible.
    In addition to being supportive of the methods, evidence, and 
conclusions presented by APHIS in the risk assessment, the reviewers 
made several useful suggestions for its improvement. We made several 
clarifications and updates in consideration of these comments. While we 
expect that the changes improve the transparency and accuracy of the 
document, they do not alter our conclusion that the risk to the United 
States of BSE--i.e., the likelihood of establishment and the potential 
impacts of cases that may occur even without establishment--resulting 
from the changes outlined in the proposed rule is negligible.

Removal of Partial Delay of Applicability of Provisions of January 2005 
Final Rule

    Our January 2005 final rule made eligible for importation from 
Canada meat that is derived from bovines slaughtered in BSE minimal-
risk regions, as well as certain other specified commodities derived 
from such bovines, provided certain specified risk-mitigating 
conditions have been met. The risk analysis we conducted for that 
rulemaking indicated a low BSE risk from such commodities derived from 
bovines of any age if certain conditions are met (APHIS 2004). These 
conditions include the removal of those tissues considered at 
particular risk of containing the BSE agent in infected animals 
(specified risk materials, or SRMs). In that rulemaking, we discussed 
regulatory requirements implemented by FSIS in 2004 that banned SRMs 
from the human food supply in the United States, and we stated that the 
Canadian Government had established similar safeguards in Canada.
    Consequently, we provided that meat, meat byproducts, meat food 
products, and offal derived from bovines are eligible for importation 
from BSE minimal-risk regions if the following conditions, as well as 
all other applicable requirements of the regulations, are met:
     The commodity is derived from bovines that have been 
subject to a ruminant feed ban equivalent to the requirements 
established by the U.S. Food and Drug Administration at 21 CFR 
589.2000;
     The commodity is derived from bovines for which an air-
injected stunning process was not used at slaughter; and
     The SRMs and small intestine of the bovines from which the 
commodity was derived were removed at slaughter.
    Additionally we provided that tallow composed of less than 0.15 
percent insoluble impurities that is not otherwise eligible for 
importation under 9 CFR 95.4(a)(1)(i), and gelatin derived from bones 
of bovines that is not otherwise eligible for importation under 9 CFR 
94.18(c) are eligible for importation from BSE minimal-risk regions, 
provided certain specified conditions are met.
    In the economic analysis we conducted for the January 2005 final 
rule, we evaluated the potential economic effects of implementing that 
rulemaking, including implementation of the provisions allowing the 
importation of meat and other commodities derived from bovines 
slaughtered in BSE minimal-risk regions (APHIS 2004a).
    In March 2005, APHIS published a document in the Federal Register 
that, pursuant to an announcement by the Secretary of Agriculture on 
February 9, 2005, delayed the applicability of the provisions in our 
January 2005 final rule as they apply to the importation from Canada of 
the following commodities when derived from bovines 30 months of age or 
older when slaughtered: (1) Meat, meat food products, and meat 
byproducts other than liver; (2) whole or half carcasses; (3) offal; 
(4) tallow composed of less than 0.15 percent insoluble impurities that 
is not otherwise eligible for importation under 9 CFR 95.4(a)(1)(i); 
and (5) gelatin derived from bones of bovines that is not otherwise 
eligible for importation under 9 CFR 94.18(c).
    In his February 9, 2005, announcement, the Secretary stated that 
because ongoing investigations into recent finds of BSE in Canada in 
animals over 30 months of age were not complete, he felt it prudent to 
delay the effective date for allowing imports of meat from bovines 30 
months of age and over. He also indicated that the delay of 
applicability would address concerns that the January 2005 final rule 
allowed the importation of beef from bovines 30 months of age or older, 
while continuing to prohibit the importation of live cattle 30 months 
of age or older for processing in the United States. The Secretary 
stated that the Department would consider and develop a plan--based on 
the latest scientific information and with the protection of public and 
animal health as the highest priority--to allow imports of live bovines 
30 months of age or older as well as beef from animals 30 months of age 
and older.
    Since the date of the partial delay of applicability of our January 
2005 final rule, we have obtained additional information regarding all 
aspects of the issues that prompted the delay of applicability and have 
conducted additional analyses in line with the plan as described. The 
risk assessment for this final rule demonstrates the negligible BSE 
risk from the importation of additional classes of live cattle, 
including those 30 months of age or older. This includes acknowledging 
the potential risk pathway that could be available if the SRMs from 
infected imported cattle entered the ruminant feed supply in 
contravention of current feed regulations. The negligible risk from the 
importation of live older cattle therefore gives further support to the 
conclusion of the risk analysis conducted for our January 2005 final 
rule regarding meat and meat products derived from bovines of any age 
in BSE minimal-risk regions. Specifically, the risk is even lower for 
the importation of meat and meat products, as the SRMs will be removed 
in accordance with the regulations, than for live bovines.
    Therefore, this document will remove the partial delay of 
applicability of the January 2005 final rule. The removal of the 
partial delay of applicability will become effective on the date that 
the other provisions of this document become applicable. Including the 
removal of the partial delay of applicability in this final rule and 
making it effective along with the other provisions of this rule will 
enable APHIS to more efficiently communicate the necessary 
implementation instructions to U.S. Customs and Border Protection and 
to APHIS field personnel. Additionally, it will provide commercial 
entities more flexibility in carrying out import planning based on the 
relative economic merits of importing live bovines or meat and other 
products derived from bovines.
    Because, for reasons of efficiency for APHIS and the regulated 
community, the Secretary has decided to remove the delay in 
applicability as part of this document, we looked at the economic 
effects of doing so in combination with allowing the importation of 
bovines born on or after March 1, 1999. Although we previously analyzed 
the economic effects of allowing the importation of meat and other 
products derived from bovines 30 months of age

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or older, the economic analysis for this rule provides an updated 
analysis.

Public Comments on the January 2007 Proposed Rule

    We solicited comments concerning our January 2007 proposal for 60 
days ending March 12, 2007. We received close to 400 comments by that 
date. The commenters included cattle industry and farm bureau 
associations, consumer groups, representatives of the Canadian 
Government and other foreign countries, State Departments of 
Agriculture, food processing companies, individual cattle producers, 
and other members of the public.

Subjects of Comments Received

    A number of commenters supported the rule and recommended no 
changes to the proposed provisions. Other commenters supported the rule 
in general but recommended certain changes or actions. Other comments 
consisted only of recommended changes, objections to the rule in 
general or to specific provisions, or requests for clarification. We 
discuss below by topic the issues raised by commenters and our response 
to those comments.

General Opposition to Imports

    Issue: A number of commenters expressed general opposition to the 
importation of any bovines or bovine products from BSE minimal-risk 
regions.
    Response: It appears to us that these commenters are not addressing 
just our January 2007 proposed rule, but, rather, also the January 2005 
final rule that recognized the category of BSE minimal-risk regions and 
established conditions for the importation of certain ruminants and 
ruminant products from such regions.
    As we discussed in the January 2005 final rule, the comprehensive 
analysis and evaluation we conducted for that rulemaking led to the 
conclusion that the conditions specified in that rule for the 
importation of ruminants and ruminant products from BSE minimal-risk 
regions would be effective and would therefore protect against the 
introduction of BSE into the United States. Our January 2007 proposed 
rule considered expansion of the types of commodities allowed 
importation from BSE minimal-risk regions, based on an evaluation of 
the risk (i.e., the likelihood of establishment and the potential 
impacts of cases that may occur even without establishment) of 
importing from Canada live animals, blood and blood products, and the 
small intestine excluding distal ileum.) Given the determination of 
negligible BSE risk associated with the provisions of this final rule, 
and the findings associated with our 2005 final rule, there is no 
scientific basis for increasing restrictions from those already in 
effect or being established in this rule.
    Issue: A number of commenters expressed opposition, without further 
explanation, to the importation from BSE minimal-risk regions of live 
bovines 30 months of age or older and to the importation of products 
derived from such bovines.
    Response: We discussed in our January 2007 proposed rule the 
rationale for our proposal to allow the importation, under certain 
conditions, of live bovines 30 months or older from BSE minimal-risk 
regions. We discussed further the assessment of the disease risk of 
allowing such imports that we conducted before issuing our proposal. It 
is not clear to us which factors in our risk assessment or discussion 
of rationale were being addressed by those commenters who expressed 
general opposition to the importation of live bovines 30 months of age 
or older. We continue to consider the BSE risk from importing live 
bovines under the conditions specified in this rule to be negligible.
    Issue: Several commenters who expressed opposition to the proposed 
rule expressed concern that the agent that causes BSE has yet to be 
fully characterized. The commenters stated that what we know about BSE 
is mostly supposition, which should be a compelling reason not to allow 
the importation of cattle from a region of known BSE outbreaks. One 
commenter stated that research recently conducted at Yale University 
suggests that one of the agents that activates BSE may be viral, which, 
according to the commenter, implies that a feed ban is effective only 
when the virus is not present or active.
    Response: As one of the commenters noted, some researchers 
(Manuelidis et al., 2007) suggest that diseases characterized as 
transmissible spongiform encephalopathies (TSEs), such as BSE, may be 
caused by viruses, although, at this point, no infection-specific 
nucleic acids have been identified.
    Experimental data and epidemiological studies strongly suggest that 
contaminated feed containing ruminant proteins derived from infected 
animals was the source of the epidemic, and that the epidemic was 
perpetuated through the use of these materials in ruminant feed. APHIS 
considers that regardless of the characteristics of the BSE causal 
agent, it is clear that the epidemic was sustained and amplified by the 
recycling of BSE infected cattle into cattle feed. Despite the 
difficulty in definitively determining the causal agent of BSE, risk 
factors for transmission of the agent have been identified. The 
identification and characterization of these risk factors through 
epidemiological and experimental study have allowed the development of 
effective mitigations to prevent BSE spread. The development and 
demonstrated effectiveness of those mitigations does not require 
identification of the agent itself. We consider mitigation measures 
that address the risk factors for BSE to be effective regardless of the 
precise nature of the BSE agent.

Prevalence of BSE in Canada

    Although the provisions of this rule apply to any region recognized 
by APHIS as a BSE minimal-risk region, at present APHIS recognizes only 
one country, Canada, as such a region. Therefore, in evaluating the BSE 
risk of implementing this rule, we conducted an assessment of the risk 
of importing bovines and bovine products from Canada under the 
provisions of our proposed rule (APHIS 2006b). In our risk assessment, 
we laid out the likely risk pathway (i.e., a series of occurrences or 
steps necessary for disease to enter and become established).
    In conducting our risk assessment, one of the factors we took into 
account was the prevalence of BSE in Canada, since prevalence is one 
factor that affects the likelihood of a BSE-infected bovine being 
imported into the United States. We received a number of comments from 
the public that addressed our estimate of the prevalence of BSE in 
Canada. Although some of the comments supported our estimate of BSE 
prevalence in Canada, in general the commenters maintained that such 
prevalence is either higher than we estimated, may be increasing, or is 
uncertain, or that our methods of estimating it were flawed. The 
methodology we used to arrive at such estimates is discussed in detail 
in our risk assessment. However, to provide some context for the issues 
raised by commenters and discussed below, we summarize here the models 
that we used in conducting our assessment.
    The number of BSE cases detected through surveillance understates 
the disease prevalence because exposed animals may be incubating 
disease and carrying infectious material in their tissues without 
presenting clinical symptoms. Like many transmissible spongiform 
encephalopathies (TSEs),

[[Page 53318]]

BSE has an incubation period of several years. Therefore, the disease 
is not detectable in its early stages with current technology. 
Moreover, surveillance will miss a proportion of detectable cases. 
Therefore, we applied statistical methods to the available 
epidemiologic and surveillance data to estimate, with attendant 
uncertainty, the prevalence of BSE in Canada.
    We used two related, but distinct, methods to estimate BSE 
prevalence in Canada: the BSurvE model and the Bayesian Birth Cohort 
(BBC) model. Given its international prominence, we used the European 
Union (EU) BSurvE model (Wilesmith et al., 2004, 2005), recently 
developed for the purpose of estimating BSE prevalence in national 
herds. The BSurvE model is noteworthy for its sound epidemiologic 
structure, including stratifying cattle by age and cause of death 
(i.e., healthy slaughter, fallen stock, casualty slaughter, or clinical 
suspect) and accounting for the relative likelihood of detecting BSE in 
various strata (EFSA 2004). The BSurvE model structure calculates BSE 
surveillance point values (random sample size equivalents) represented 
by targeted Canadian sampling of certain groups of cattle in which BSE 
cases are more likely to be detected. This approach allows for the 
inclusion of infected, but undetected, cases (such as young animals in 
the early stages of incubation) in the estimate, which would be ignored 
by conventional methods.
    The other prevalence estimation model that we used is the BBC 
model. This model uses the BSurvE model structure and incorporates 
additional information. Unlike BSurvE, the BBC model adopts a Bayesian 
statistical framework to incorporate prior information about the 
decreased incidence of BSE observed in animals born after a feed ban 
equivalent to the initial ruminant-to-ruminant feed ban introduced in 
the United Kingdom in 1988.
    Issue: One commenter stated that BSE has become ``firmly 
established'' in Canada.
    Response: We disagree with the comment, which we consider to 
erroneously equate disease presence, which may be transient, with 
disease establishment. In epidemiology, an infectious disease has 
become established in a population when the disease is perpetuated in 
the population without the need for reintroduction from an external 
source. For example, OIE's sister agency, the international Commission 
on Phytosanitary Measures (CPM) defines plant pest establishment as 
``the perpetuation, for the foreseeable future, of a nonindigenous 
biological agent within an area after entry'' (CPM 2001). With the 
implementation and continuation of a feed ban in Canada, all evidence 
points toward eventual eradication, rather than perpetuation of BSE in 
that country.
    Issue: One commenter stated that, since the time APHIS published 
its January 2005 final rule classifying Canada as a BSE minimal-risk 
region, the Agency has presented no new evidence that would support 
allowing the importation from Canada of the additional commodities 
discussed in the proposed rule. In fact, stated the commenter, evidence 
points to Canada having a higher prevalence of BSE than APHIS had 
previously determined.
    Response: As discussed in our January 2007 proposed rule, we 
revisited our earlier conclusions and policies by conducting a rigorous 
risk assessment based on current available scientific knowledge of the 
disease. We used peer reviewed risk assessment models in our analysis 
to estimate the prevalence of the disease in Canada and to analyze the 
likelihood of BSE establishment in the United States and the potential 
impacts of cases that may occur even without establishment as a result 
of the importation into the United States of the bovine commodities 
considered in this rule. The risk assessment itself was peer reviewed 
by experts in the field. As noted above, the reviewers agreed with the 
conclusion that the risk of establishment of BSE in the U.S. cattle 
population is negligible and noted that several assumptions in the risk 
assessment actually over-estimate the risk, so the overall finding that 
the BSE risk is negligible is reasonable. Based on the results of the 
risk assessment, we concluded that we could safely import Canadian 
cattle born on or after March 1, 1999, blood and blood products, and 
small intestines, excluding the distal ileum.
    Issue: Several commenters raised questions about the ability to 
statistically determine BSE prevalence ``trends'' in Canada, but 
reached different conclusions. Some commenters stated that the 
trajectory of BSE prevalence in Canada cannot be determined by 
available surveillance data and that, therefore, BSE prevalence in 
Canada may be increasing. On the other hand, another commenter 
requested that APHIS make clear that, despite the Agency's use of the 
BSurvE Prevalence B estimate, prevalence should not be assumed constant 
over time. The commenter requested that APHIS emphasize that lack of 
statistical evidence that prevalence varies from cohort to cohort is 
likely the result of inadequate statistical power,\2\ and that, 
nevertheless, BSE prevalence in Canada is most likely decreasing.
---------------------------------------------------------------------------

    \2\ The power of a statistical test is the probability of 
rejecting the null hypothesis when it is false. The power depends on 
the test level of significance, the magnitude of effect under the 
alternative hypothesis, sample size, and variability in the 
population. Rice (1988, pp.361-364) describes the calculation of 
statistical power for comparing two independent samples.
---------------------------------------------------------------------------

    Response: In our risk assessment for this rule, we acknowledge 
that, given the rarity of BSE cases in Canada, the surveillance data 
are unlikely to provide adequate statistical power to detect any trend. 
However, as discussed in the risk assessment, we consider it likely 
that the prevalence of BSE in Canada will decrease over time. With so 
few total BSE cases observed in Canada, the statistical power to detect 
differences in prevalence between cohorts is low. The peer reviewers of 
our risk assessment concur with our conclusion. (RTI 2007, pp. 6-26, 6-
27).
    Issue: One commenter estimated the Canadian BSE prevalence to be 
6.4 cases per million cattle. Further, the commenter stated that this 
prevalence estimate is smaller than the risk estimate provided by one 
of APHIS' own risk assessments for a more pessimistic value of the 
misfeeding rate. The commenter suggested that this discrepancy reflects 
optimistic modeling assumptions in APHIS' risk assessment.
    Response: We disagree with the commenter's analysis. Although the 
commenter's alternative prevalence estimate, based on a simple 
extrapolation method, falls within the 90 percent confidence interval 
\3\ of APHIS' BSurvE Prevalence B estimate (2.4 to 6.8 cases per 
million adult cattle) with an expected value of 3.9 per million case 
per million adult cattle (APHIS 2006c, table 5), it is based on 
different assumptions. Based on an analysis of BSE testing in the EU in 
2001 and 2002, the commenter's prevalence estimate assumes that 
targeted ``risk cattle'' are only 10 times more likely to test positive 
for BSE than non-targeted routinely slaughtered cattle. Considering the 
BSE testing conducted in the EU during 2001-2004 (EC 2005a, table 3, p. 
23), cattle in the

[[Page 53319]]

European BSE risk animals category (emergency slaughter, clinical 
suspects, and fallen stock) are 22 times more likely to test BSE 
positive than cattle in the healthy slaughter category. Using the 
commenter's simple extrapolation method and these more up-to-date data 
on BSE test positive ratio, the resulting BSE prevalence estimate would 
be 2.9 per million cattle. Although actually lower than the expected 
value for the BSurvE estimate, this value also falls within the 90 
percent confidence interval of the Agency's BSurvE Prevalence B 
estimate, described above. APHIS calculated both the BSurvE Prevalence 
B estimate and the Bayesian Birth Cohort (BBC) prevalence estimate, but 
judged the latter to better characterize the BSE prevalence in Canada 
over the next 20 years, due to the expected downward pressure exerted 
on the disease by a feed ban.
---------------------------------------------------------------------------

    \3\ A confidence interval is a statistical range with a 
specified probability that a given parameter lies within the range. 
For example, the 90 percent confidence interval of a distribution 
indicates the range of values that we are 90 percent certain include 
the parameter value of interest. It extends from the 5th percentile, 
or 5 percent confidence level, at the low end of the distribution of 
the 95th percentile, or 95 percent confidence level at the high end 
of the distribution. Similarly, a 95 percent confidence interval 
would extend from the2.5 percent confidence level to the 97.5 
percent confidence level.
---------------------------------------------------------------------------

    With regard to the commenter's suggestion of a discrepancy, the 
commenter provides no specific reference to ``the risk estimate 
provided by one of APHIS' own risk assessments,'' but appears to refer 
to the main body of the 2005 report of Cohen and Gray (available at 
http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Report_2005.pdf), 
which was prepared for the USDA's Food Safety and Inspection Service 
(FSIS). Cohen and Gray (2005) do not estimate Canadian BSE prevalence, 
but rather the effect of introducing 500 BSE-infected cattle into the 
United States, and the pessimistic misfeeding assumption estimates that 
introduction would result in an expected 2,600 new cases over 20 years. 
There is no discrepancy because this aspect of the Cohen and Gray 2005 
report is not relevant to our estimate of Canadian BSE prevalence.
    Issue: Based on APHIS'' statements that animals are infected within 
their first year, and that feed produced prior to the feed ban would 
not be available for longer than a year, one commenter stated that 
additional undetected infected animals must have existed and been 
rendered in order to provide infectivity to detected cases. Therefore, 
stated the commenter, adding in these ``undetected'' animals raises the 
number of Canada's known and measurable BSE cases rises from 10 to 14, 
and APHIS' estimate of BSE prevalence in Canada based on 10 animals is 
low.
    Response: We disagree with the commenter's analysis and conclusion, 
which assumes that we did not take into account the possibility of 
undetected cases of BSE in arriving at our prevalence estimate. APHIS' 
estimate of the prevalence of BSE in Canada was adjusted to account for 
cases that would not be tested and for false negative test results. 
Also, although the bulk of feed will be consumed within a year after it 
is produced, residual infectivity may remain in the feed supply chain 
for an extended period. For example, examination of BSE cases in 
animals born in the United Kingdom after the 1996 ``reinforced feed 
ban'' suggests that these animals may have been infected from the 
persistence of the BSE agent in residual feed in storage bins (SEAC 
2005).
    Issue: One commenter suggested that it is likely that Canada has 
numerous cattle over 30 months of age that are presently incubating the 
BSE disease, rather than just a few (4.1) as suggested by APHIS.
    Response: The estimate of 4.1 BSE-infected animals in the standing 
Canadian adult cattle population was based on the expected BSE 
prevalence in Canada under the BBC model. Using the estimated 
prevalence under BSurvE Prevalence B resulted in an estimate of 23.2 
BSE-infected animals in the standing Canadian adult cattle population. 
Although, quantitatively, our risk assessment did not assume a decline 
in BSE prevalence over the next 20 years, we qualitatively consider 
such a decline to be likely because of continued compliance with the 
feed ban. Therefore, in assessing the BSE risk associated with imports 
from Canada over the next 20 years, we consider the result of the BBC 
model to be the more applicable prevalence estimate for use in our 
quantitative exposure model.
    Issue: One commenter indicated that although it is unclear whether 
the APHIS estimates of Canadian BSE prevalence included the BSE case 
confirmed on August 23, 2006, the APHIS estimates certainly do not take 
into account the case confirmed on February 7, 2007.
    Response: We estimated Canadian BSE prevalence based on a 7-year 
surveillance period through August 15, 2006. This surveillance period 
included the detection of nine BSE cases of Canadian origin reported 
through August 2006. Through surveillance conducted from August 16, 
2006, through April 2007, Canada detected one BSE case born in 2000 and 
another born in 2001 (CFIA 2007). The BSE prevalence estimation methods 
used by APHIS (2006a) require detailed data to stratify tested cattle 
by age and cause of death (healthy slaughter, fallen stock, casualty 
slaughter, or clinical suspect) that are unavailable for the more 
recent surveillance period. However, we can assess the sensitivity of 
our previous Canadian BSE prevalence estimates by adding the two 
additional cases without changing the BSE surveillance points 
accumulated by Canada during the 7-year surveillance period through 
August 15, 2006 (APHIS 2006a, table 4). \4\ This approach results in a 
revised table of BSurvE points and BSE cases by birth year cohort that 
reflects a total of 11 BSE cases of Canadian origin reported through 
April 2007 (APHIS 2007, table i).
---------------------------------------------------------------------------

    \4\ In the BsurveE model, specific ``point values'' are assigned 
to each test sample, based on the surveillance stream or 
subpopulation of animals from which it was collected, as well as the 
likelihood of detecting infected cattle in that subpopulation. A 
sample from the specific surveillance subpopulation where BSE is 
most likely to be detected--i.e., a middle adult clinical suspect--
provides the most surveillance points. Conversely, a sample from the 
subpopulation where BSE is least likely to be detected--generally 
routine slaughter--provides the least points.
---------------------------------------------------------------------------

    Using the same methods described in USDA's estimate of BSE 
prevalence in Canada (APHIS 2006c), we obtain updated Canadian BSE 
prevalence estimates:
     BSurvE Prevalence B: 90 percent confidence interval = 3.0-
8.0 cases per million adult cattle
     Bayesian Birth Cohort (BBC, Winbugs): 90 percent 
confidence interval = 0.47-1.2 cases per million adult cattle
    Because the updated confidence intervals contain the previous 
expected value estimates of 0.68 per million (BBC) and 3.9 per million 
(BSurvE Prevalence B) (APHIS 2006c), we conclude that the prevalence 
estimate is not sensitive to the addition of the two additional BSE 
cases discovered in Canada in August 2006 and February 2007.
    Issue: One commenter stated that APHIS' expectation that the 
prevalence of BSE in Canada will continue to decline from its present 
minimal level does not acknowledge that the prevalence of BSE in Canada 
right now is very uncertain. The commenter's independent estimate of 
the current Canadian BSE prevalence is ``on the order of 4-6 per 
million.''
    Response: APHIS' risk assessment addresses the uncertainty in the 
prevalence of BSE in Canada by considering estimates that differ by 
more than a factor of five (APHIS 2006b). The BBC prevalence estimate 
has an expected value of 0.68 cases per million adult cattle.\5\ The 
BSurvE Prevalence B estimate has an expected value of 3.9 per million. 
The

[[Page 53320]]

commenter's own method of estimation--``on the order of 4-6 per 
million----provides an estimate on the same order of magnitude as the 
BSurvE Prevalence B estimate of current prevalence. In either case, 
prevalence is extremely low.
---------------------------------------------------------------------------

    \5\ The BBC model provides a more precise estimate of BSE 
prevalence in Canada by combining the epidemiologic theory and 
application of surveillance data underlying the BSurvE model with 
additional information about the effect of the feed ban on 
prevalence.
---------------------------------------------------------------------------

    Issue: One commenter stated that, although APHIS estimates that BSE 
prevalence in Canada is about 6.8 or more times greater than in the 
United States (0.68 vs. 0.1 per million), this does not adjust for the 
important fact that the first BSE case in the United States was 
imported from Canada.
    Response: The APHIS October 2006 estimate of BSE prevalence in 
Canada is based on the nine BSE cases of Canadian origin that had been 
confirmed in North America as of August 23, 2006. This total includes a 
case of BSE that was confirmed in Washington State on December 25, 2003 
(APHIS 2006c, p. 1). The estimate of BSE prevalence in the United 
States excludes this case.
    Issue: One commenter stated that the calculation of BSE prevalence 
in Canada used in APHIS' risk assessment excluded the European-born 
case detected in 1993.
    Response: The 1993 Canadian BSE case of European origin was likely 
part of the original exogenous source of BSE infectivity introduced 
into Canada that caused the subsequent generation of indigenous cases. 
Imported cases of BSE reflect an exposure to the disease that occurred 
elsewhere, and, therefore, are not generally included in estimates of 
prevalence that reflect native exposure. Similarly, when APHIS 
estimated the prevalence of BSE in the United States, the BSE-infected 
cow of Canadian origin that was detected in Washington State in 
December 2003 was excluded from the analysis, because it was an 
imported animal. In addition, as noted in APHIS' estimation of BSE 
prevalence in Canada (APHIS 2006c, p. 5), in accordance with OIE 
guidelines (which indicate that surveillance points totals taken into 
account in assessing a country's BSE risk be accumulated over a maximum 
of 7 consecutive years), the estimated prevalence of BSE in Canada is 
based on surveillance data accumulated over a 7-year period beginning 
August 16, 1999. The 1993 case predates the OIE 7-year period.
    Issue: One commenter indicated that APHIS should not take action on 
the proposal until real surveillance data (not model-based predictions) 
show that the BSE problem has abated. The commenter stated further that 
denying Canada's BSE problem, or assuming it away with unvalidated and 
incorrect risk modeling assumptions, does not responsibly manage BSE 
risks to the United States.
    Response: We disagree with the commenter. In low BSE prevalence 
populations such as Canada, surveillance at levels that meet or even 
greatly exceed OIE guidelines provide insufficient statistical power to 
reliably detect changes in BSE prevalence over time. In other words, 
starting with a very low number of infected animals makes it very 
difficult to statistically demonstrate decreases in that number, even 
when testing a relatively large number of animals.
    The OIE Guidelines for BSE Surveillance (Type A) call for countries 
to accumulate 300,000 BSE surveillance points over 7 consecutive years 
in order to detect with 95 percent confidence a prevalence level of at 
least one case of BSE per 100,000 animals (OIE 2006, Appendix 3.8.4).
    To illustrate the comparative difficulty in demonstrating trends in 
low versus high prevalence populations, consider two hypothetical 
countries that have accumulated 1 million BSE surveillance points for 
each of two cohorts: Animals born before and animals born after the 
introduction of a ruminant-to-ruminant feed ban. Under this scenario, 
sampling levels in both countries far exceed the OIE guidelines. 
Assume, however, that the two countries differ with respect to their 
initial prevalence--i.e., the initial prevalence in ``Country A'' is 1 
infected animal per 10,000 animals, while that in ``Country B'' is 1 
infected animal per 100,000 animals.
    For a given surveillance level, the statistical power of a 
hypothesis test can be evaluated as a function of the supposed change 
in BSE prevalence between cohort 1 (pre-feed ban) and cohort 2 (post-
feed ban). The conventional minimum statistical power criterion is 80 
percent. In other words, the probability that a statistical analysis 
will detect a true difference across groups should be at least 80 
percent. The conventional significance level is 5 percent, meaning that 
we would conclude that a result was nonrandom if it were 5 percent or 
less likely to occur by chance alone. In our hypothetical scenario, the 
power of the surveillance in the country with higher prevalence, 
Country A, to detect a 50 percent decline in BSE prevalence is 98 
percent. In comparison, the power of the surveillance in the lower 
prevalence Country B to detect a 50 percent decline in BSE prevalence 
is only 25 percent. In other words, if the Country B feed ban actually 
led to a 50 percent decline in BSE prevalence and the equivalent of 2 
million random samples were collected (6.7 times the level under the 
OIE guidelines), there would still be a 75 percent chance of concluding 
that the prevalence was unchanged from its initial level of 1 infected 
animal per 100,000 animals.
    An important implication of the low statistical power of sampling 
in low prevalence populations is that BSE surveillance data are 
unlikely to provide a purely statistical basis for making a 
determination about the date when a specific intervention (e.g., a 
ruminant-to-ruminant feed ban) becomes effective, even when large 
amounts of surveillance data are available. For example, according to 
the OIE (2007a), the annual incidence of reported BSE cases in the 
Netherlands dropped from 13.2 to 0.8 per million adult cattle from 
2001-2005.\6\ Despite the EU BSE surveillance requirements for testing 
all risk animals over 24 months of age and all healthy slaughter cattle 
over 30 months of age, Figure 1 shows that application of the BSurvE 
(Prevalence A) model to Netherlands BSE surveillance data does not 
yield sufficient statistical power to draw clear distinctions among 
birth year cohorts as prevalence declines (Figure 1).
---------------------------------------------------------------------------

    \6\ The OIE Terrestrial Animal Code (Chapter 1.1.1., Article 
1.1.1.1) defines incidence as ``the number of new cases or outbreaks 
of a disease that occur in a population at risk in a particular 
geographical area within a defined time interval (OIE 2006b).''

---------------------------------------------------------------------------

[[Page 53321]]

[GRAPHIC] [TIFF OMITTED] TR18SE07.023

    Note that, in figure 1, there is a decrease in estimated prevalence 
between 1998 birth-year cohorts and 1999 birth-year cohorts, while, at 
the same time, there is an increase in the upper confidence limit. This 
apparent paradox is indicative of another shortcoming of relying on 
surveillance data alone to determine whether BSE prevalence has been 
reduced. Because fewer animals from the most recent birth year cohorts 
are tested when sent to slaughter, uncertainty about the prevalence in 
the most recent cohorts is much greater than in older cohorts. 
Furthermore, the lower likelihood of detecting BSE in young infected 
animals means that the young animals that are tested contribute 
relatively little to reducing uncertainty in the true (as opposed to 
apparent) BSE prevalence. These two sources of uncertainty in young 
birth cohorts (low numbers of animals tested, and little value in the 
surveillance data that are gathered from them) cause an asymmetrical 
increase in the upper limit of the confidence interval compared to the 
lower confidence limit. This effect on the upper confidence limit on 
BSE prevalence is most pronounced for the most recent birth year 
cohorts which are less likely to be tested and will not have lived long 
enough to manifest BSE, even if they have been infected. Wilesmith et 
al. (2004, figure 3) further illustrates this same concept.
    Consequently, if the effectiveness of a country's safeguards 
against BSE amplification were determined strictly by setting a 
tolerance for the upper confidence limit on BSE prevalence associated 
with the ``real surveillance data,'' one might reach the incorrect 
conclusion that prevalence is increasing, when in actuality, the result 
is simply due to testing fewer and younger animals in the most recent 
birth year cohorts. Finally, relying solely on surveillance data fails 
to account for under reporting of disease due to the lack of diagnostic 
sensitivity to detect BSE at an early stage of disease. By accounting 
for the possibility of false negative test results, epidemiologic 
models such as BSurvE are recognized as providing a more accurate 
estimate of true BSE prevalence than the apparent prevalence measured 
by surveillance data alone.
    Issue: One commenter stated that the output from the BSurvE model 
used by Canada in 2005 grossly underestimated Canada's 2006 and 2007 
BSE prevalence and, therefore, the BSurvE model is unreliable for 
estimating Canada's BSE prevalence. The commenter stated further that, 
at the minimum, APHIS should determine the erroneous inputs that 
resulted in the failed prediction in 2005 and correct them.
    Response: In the risk assessment conducted for this rulemaking, 
APHIS used its own prevalence estimate, not that of the Canadian Food 
Inspection Agency's (CFIA's) 2006 prevalence estimate, which was not 
based on BSurvE, but on a modified version that appears similar to the 
APHIS BBC model. The commenter cites CFIA's Assessment of the North 
American BSE Cases Diagnosed from 2003-2005 (Part II), which states 
that ``when the BSurvE model was recently applied to Canada's 
statistics and adjusted to account for the effectiveness of the 1997 
feed ban (based on experiences with the 1988 feed ban in the United 
Kingdom), the resulting prediction was that it could be expected that 
three infected animals remain within the national herd'' (CFIA 2006, p. 
13).
    APHIS' estimation of BSE prevalence in Canada (APHIS 2006c) is that 
the expected prevalence values under the BBC and BSurvE Prevalence B 
models correspond to an expected number of BSE-infected animals in the 
standing Canadian adult cattle population of 4.1 and 23.2, 
respectively. APHIS further explains that it is important to note that 
this range of prevalence estimates represents uncertainty and not 
variability. BSE-infected animals are recruited into and exit from the 
adult cattle population over time, but at a given point in time, the 
number of infected animals in the population is a fixed but uncertain 
value.
    Assuming the overall probability of infection remains constant over 
time, the actual number of infected cattle in the population at any 
given point in time would still vary randomly about the mean. This 
variability is incorporated in the model supporting the exposure 
assessment for live bovines by means of the Poisson variability 
distribution. Assuming a fixed mean prevalence of 4.1 and 23.2 BSE 
infected animals in the standing adult cattle population in Canada, the 
95th percentile of the Poisson distribution are 7 and 31 BSE-infected 
animals in any given year, respectively. We note that these numbers are 
greater than the

[[Page 53322]]

five BSE cases detected in Canada in 2006, which means that the 
greatest number of Canadian BSE cases identified in a single 
surveillance year is lower than even the 95th percentile of 
distribution.
    Issue: One commenter stated that, if the United States were finding 
BSE cases at the same rate as in Canada, this would translate into 
roughly 40 BSE cases detected in the United States since January 2006, 
which would be regarded as a large number. The commenter stated further 
that, at this time, the BSE situation in Canada does not appear to be 
improving.
    Response: We do not agree with the commenter. The commenter's 
conclusion appears to be based on a cursory estimate and does not 
provide an accurate comparison of BSE cases detected in Canada with a 
comparable number that would have been detected in the United States, 
given the larger U.S. cattle population. The commenter's comparison 
fails to take into account other years of surveillance, as well as the 
age and surveillance stream of tested animals. These data are extremely 
important for estimating BSE prevalence. A comparison based solely on 
the number of detected cases ignores infected animals with unapparent 
or undetected infections.
    Table 1 provides a direct comparison of the estimated BSE 
prevalence in the current standing adult cattle population of the 
United States and Canada, respectively, using identical estimation 
methods (APHIS 2006a; 2006c).

Table 1.--Comparison of Estimated BSE Prevalence in the Current Standing
               Adult Cattle Population of U.S. and Canada
------------------------------------------------------------------------
                                     BSE Prevalence Estimation Method
                                ----------------------------------------
            Country               BSurvE  prevalence
                                          B                   BBC
------------------------------------------------------------------------
                                              Expected value
------------------------------------------------------------------------
US.............................  0.18 x 10-6........  0.10 x 10-6
Canada.........................  3.9 x 10-6.........  0.68 x 10-6
------------------------------------------------------------------------

    Despite the higher estimated BSE prevalence in the current standing 
adult cattle population in Canada compared to the prevalence of BSE in 
the standing adult cattle population in the United States, APHIS finds 
that, because of the extremely low BSE prevalence in Canada and the 
high levels of BSE controls in both Canada and the United States, the 
risk to the United States (i.e., the likelihood of establishment of BSE 
in the United States and the potential impacts of cases that may occur 
even without establishment) as a result of importing from Canada the 
bovine commodities considered in this rule is negligible (APHIS 2006b). 
Furthermore, as stated in our risk assessment, we expect that the 
prevalence of BSE in Canada will decrease continuously over the next 
several years. Peer reviewers of our risk assessment agreed (RTI 2007).
    Issue: One commenter stated that Canada's ratio of positive cases 
per 10,000 cattle tested exceeds the ratio of 22 of the 25 EU-member 
countries; that only the ratios for the United Kingdom, Portugal, and 
Spain exceed Canada's 2006 ratio. The commenter noted further that even 
the countries of Ireland, Germany, and France, each of which are 
considered to have had widespread BSE exposure, have a lower ratio for 
positive cases detected per 10,000 head tested than does Canada. 
Another commenter stated that Canada's BSE prevalence is higher than 
that for Denmark, Belgium, and Austria, and is comparable to the rate 
in Germany. This commenter, who estimated the Canadian BSE prevalence 
to be 6.4 cases per million cattle, stated further that no one 
considers countries with a reported BSE rate of 1 to 2 cases per 
million animals (e.g., Denmark, Belgium and Austria) to have a minimal 
BSE risk, and that Canada is not a BSE minimal-risk region in any 
ordinary sense.
    Response: The commenters' statements ignore important differences 
in BSE surveillance and cattle populations among countries, and a 
comparison based simply on the proportion of positive cases per number 
of cattle tested is inconsistent with the prevalence estimate approach 
taken by one of the commenters, as well as the prevalence estimate used 
by APHIS. Although calculating the proportion of infected animals 
detected per number of tested animals can serve as a useful tool, 
depending on the purpose for the calculation, it is not an estimate of 
prevalence. Rather, prevalence is defined as the number of infected 
animals in the total population at a given point in time. On the other 
hand, the calculation conducted by the commenter who referred to the 
ratio of positive cases per 10,000 cattle tested is similar to that 
conducted by the U.S. Department of Health and Human Services, Centers 
for Disease Control and Prevention (CDC). In May 2007, using data 
similar to that analyzed by APHIS for this rulemaking, CDC calculated 
the proportion of Canadian-born BSE cases identified by Canadian 
authorities in relation to the total number of animals tested in that 
country. CDC then made a like calculation regarding BSE cases in U.S.-
born cattle and compared the Canadian and U.S. results (CDC 2007). 
Unlike the estimate used by APHIS in the risk assessment for this rule, 
the CDC calculation is not an estimate of the prevalence of BSE in 
Canada, nor of the prevalence in the United States. Although the type 
of calculations conducted by CDC can be useful in comparing relative 
proportions of BSE detections per number of cattle tested, they do not, 
as noted above, constitute an estimate of prevalence.
    The number of disease detections per total number of animals tested 
can be influenced by the criteria used for choosing animals for 
testing. For instance, Canada, like the United States, conducts 
targeted BSE surveillance, sampling those animals where disease is most 
likely to be detected if present. In contrast, EU countries routinely 
test large numbers of healthy animals at slaughter. Approximately 80 
percent of cattle tested for BSE in the EU during 2001-2004 were 
healthy slaughtered animals, but ``risk animals'' were 22 times more 
likely to test positive (EC 2005a). One study (Giovannini et al., 2005) 
estimates the true prevalence of BSE infection in several EU countries. 
Based on BSE testing in 2001, although Denmark, Finland, and the 
Netherlands had a lower proportion of positives per test than Canada, 
the estimated prevalences from this study for those three countries 
were higher than the expected values of our Canadian BSE prevalence 
estimates using the BBC estimation method (0.68 cases per million adult 
cattle) or BSurveE Prevalence B (3.9 cases per million adult cattle). 
Giovannini et al. (2005) estimated the following 90 percent confidence 
intervals for the prevalence of BSE infection: Denmark, 9 to 38 cases 
per million animals; Finland, 29 to 110 cases per million animals; and 
Netherlands, 8 to 34 cases per million animals. The methods used by 
APHIS to estimate Canada's BSE prevalence, including the BSurvE model 
developed by the EU Transmissible Spongiform Encephalopathies Community 
Reference Laboratory, account for the cattle population demographics, 
the age and surveillance category of animals tested, and the 
insensitivity of BSE diagnostics with regard to detection of the 
disease at an early stage of development.
    The comments are based on an inappropriate comparison of a 
statistical estimate of the true BSE prevalence in Canada to the crude 
rate. Table 2 below compares the crude reported BSE rates in all five 
countries in 2005. Comparing the reported BSE rate of Canada to those 
of the countries listed by the commenters shows that Canada's

[[Page 53323]]

reported rate is at least an order of magnitude below that of the 
others.

               Table 2.--Reported BSE Rates in 5 Countries
------------------------------------------------------------------------
                                                           Reported BSE
                                                            cases per
                        Country                           million adult
                                                           cattle--2005
------------------------------------------------------------------------
Canada.................................................            0.145
Denmark................................................            1.289
Belgium................................................            1.448
Austria................................................            2.114
Germany................................................           4.965
------------------------------------------------------------------------
Source: OIE (2007a).

    The problem with comparing the crude reported rate of BSE detection 
to the estimated true BSE prevalence is illustrated by the situation in 
Belgium. The reported rate of BSE in Belgium peaked in the 2001 
surveillance year at 28.22 cases detected per million adult cattle (OIE 
2007a). In comparison, Saegerman et al. (2004) applied the BSurvE model 
to the Belgian BSE surveillance data and estimated that the actual BSE 
prevalence in Belgium peaked at approximately 400 cases per million 
adult cattle in the 1995 birth year cohort. (The lag between the 1995 
birth year and the 2001 surveillance year is consistent with the long 
BSE incubation period.)
    With regard to the comment that countries with 1 to 2 cases per 
million animals are not considered to present minimal risk, APHIS notes 
that, prior to the 2005 revisions in the OIE guidelines on BSE, 
countries with a reported BSE rate of 1 to 2 cases per million animals 
could satisfy the prevalence criterion for the pre-2005 OIE BSE 
minimal-risk classification. Under the 2004 OIE Terrestrial Animal 
Health Code (Article 2.3.13.5), the criteria for a BSE minimal-risk 
country included a reported rate of less than two cases per million 
during each of the last four consecutive 12-month periods within the 
cattle population over 24 months of age. The OIE Code was modified in 
2005 to include a revised country categorization system which more 
accurately reflected current scientific understanding of BSE. These 
modifications streamlined the number of country categories to three 
(negligible, controlled, or undetermined BSE risk) and also eliminated 
the numeric prevalence criteria for classifying the BSE risk status. 
The previous OIE minimal-risk category is now incorporated into the 
controlled risk category. We note that in 2007, the OIE recognized 
Switzerland as a BSE controlled risk region. Switzerland had a reported 
rate of 5.4 BSE cases per million adult animals in 2006 (OIE 2007a), 
greater than the 1 to 2 cases per million animals cited by the 
commenters.
    APHIS disagrees with the commenter's statement that Canada does not 
qualify as a BSE minimal-risk region. APHIS regulations at Sec.  94.0 
define the standards for a region to be designated as a minimal-risk 
region. These include the standard that the region maintain ``risk 
mitigation measures adequate to prevent widespread exposure and/or 
establishment of the disease.'' Canada continues to meet this standard. 
The commenters provided no specific evidence to document how or why 
Canada does not meet the APHIS standards.
    Issue: One commenter stated that the prior information [information 
using data from the United Kingdom feed ban] incorporated into the 
Bayesian models used to estimate prevalence of BSE-infected cattle in 
Canada may have resulted in estimates that are biased downward (to a 
limited degree) from the true burden. However, stated the commenter, 
the Bayesian models used to estimate prevalence in Canada (as of August 
2006) are basically sound and a better approach than relying on the 
BSurvE Prevalence B estimate. Further, said the commenter, given the 
proviso that the models could overestimate the effectiveness of the 
feed ban, it is most likely that the actual prevalence of infected 
animals is between 0.68 and 3.9 animals per million adult cattle. The 
commenter stated that because it is likely that the Canadian feed ban 
was at least as effective as the initial United Kingdom feed ban, and 
based on available data, the true BSE prevalence in Canada is probably 
substantially closer to 0.68 cases per million animals than to 3.9 
cases per million animals.
    Conversely, several commenters suggested that APHIS rejected the 
higher prevalence estimate of the BSurvE model for the lower prevalence 
estimate of the BBC model, and that the BBC model prevalence estimate 
is not realistic in light of recent data.
    Response: Although APHIS considered the results of both the BSurvE 
and the BBC prevalence estimation models, we consider the result of the 
BBC model as the more likely prevalence estimate to apply to the 
assessment of BSE risks associated with imports from Canada over the 
next 20 years in our quantitative exposure model, for the following 
reasons. APHIS estimated Canadian BSE prevalence based on surveillance 
conducted through August 15, 2006. (Note: This time period includes all 
cases of Canadian origin reported through August 2006 (APHIS 2006c).) 
From August 16, 2006, through April 2007, Canada accumulated 
approximately 44,980 additional BSE samples and detected two BSE cases 
(one confirmed on February 7, 2007, and another confirmed on May 2, 
2007). Based on the negative binomial likelihood ratio, which considers 
the number of negative tests prior to one or more positives, the BSurvE 
Prevalence B estimate (with expected value of 3.9 cases per million 
animals) is indeed far more likely to be true than is the BBC 
prevalence estimate (with an expected value of 0.68 cases per million 
animals) for the current standing Canadian cattle population. However, 
the primary purpose of characterizing BSE prevalence in Canada's 
current standing herd (APHIS 2006c) was not to discuss or assume its 
implications for the present, but rather, to estimate prevalence for 
use as an input for the Harvard exposure model used in the Exposure 
Assessment of the analysis. Because BSE has a long amplification cycle 
(it takes an average of 7 years from the time that one animal is 
exposed, to the time that another might be exposed from infectivity 
produced by the first animal), the Harvard model is typically run with 
20-year simulations to include roughly 3 amplification cycles. The 
prevalence estimates contained in APHIS' estimation of BSE prevalence 
in Canada (APHIS 2006c) are applied, unchanged, to the cattle imports 
projected over the next 20 years (2007-2026). Since we expect that the 
true prevalence will drop from its current level (whatever that may 
be), we anticipate that the lower, BBC estimate is a more realistic 
prediction (or even an overestimate) of average prevalence levels over 
this time frame. Consequently, APHIS considers the result of the BBC 
model, which incorporates the effect of a feed ban, to be better for 
application to the quantitative assessment of BSE risks associated with 
imports from Canada over this time period. In order to determine the 
impact of this assumption on the results, we applied the BSurvE 
estimate to the exposure model. We note that the likelihood of BSE 
establishment remained negligible (R0 of 0.079, which is far 
less than 1), as did the potential impact of cases even without 
establishment (less than 4 clinical cases) over the 20 years of the 
analysis.
    Issue: One commenter suggested that the APHIS risk model is not 
trustworthy because it has not been shown to have predictive validity 
and does not explain or predict a sustained flow of BSE cases from one 
geographic area (the Alberta region in Canada).

[[Page 53324]]

    Response: It is not clear to us from the comment which model the 
commenter is referring to. Consequently, in this response, we discuss 
the Harvard model and the prevalence models used by APHIS. In either 
case, we disagree with the commenter's conclusion that the APHIS risk 
model is not trustworthy. The plausibility of the Harvard model was 
established by comparing its predictions for Switzerland against the 
observed progression of BSE within that country's cattle herd (Cohen et 
al., 2003). It is not clear from the comment how the predictive 
validity of an infectious disease model is to be demonstrated over a 
20-year time horizon, or how the model has failed to explain or predict 
the observed data. Regarding a sustained flow of BSE cases from one 
geographic area, assuming a constant proportion of BSE infected cattle 
in the herd, more BSE cases are found where large cattle populations 
exist.
    As we discuss above in response to another issue raised by 
commenters, APHIS' estimation of BSE prevalence in Canada (APHIS 2006c) 
concludes that the expected prevalence values under the BBC and BSurvE 
Prevalence B models correspond to an expected number of BSE-infected 
animals in the standing Canadian adult cattle population of 4.1 and 
23.2, respectively. Further, the prevalence estimates represent 
uncertainty and not variability. At any given point in time, the number 
of infected animals in the population is a fixed (although uncertain) 
value, although over time the actual number of infected cattle in the 
population would vary randomly about the mean of the probability 
distribution, as BSE-infected animals are recruited into and exit from 
the adult cattle population (i.e., some are newly infected and some 
die). Even assuming that the probability of infection remains constant, 
over time the actual number of infected cattle in the population would 
vary. This variability is incorporated in the model supporting our 
exposure assessment for live bovines by means of the Poisson 
variability distribution. Assuming a fixed mean prevalence of 4.1 and 
23.2 BSE-infected animals in the standing adult cattle population in 
Canada, the 95th percentile of the Poisson distribution is respectively 
7 and 31 BSE-infected animals in any given year. As we noted above, 
these numbers are greater than the five BSE cases detected in Canada in 
2006, which means that the greatest number of Canadian BSE cases 
identified in a single surveillance year is lower than even the 95th 
percentile of distribution. While this observation does not 
statistically validate (confirm) the APHIS estimates of Canadian BSE 
prevalence, neither does it invalidate them, as the commenter seems to 
suggest. Furthermore, the prevalence estimates are applied not only to 
the current standing population, but also to the next 20 years.

BSE Data From the United Kingdom

    In our January 2007 proposed rule and its supporting risk 
assessment, we discussed data associated with a ruminant-to-ruminant 
feed ban in the United Kingdom and indicated that experience in the 
United Kingdom demonstrates that implementation of a ruminant-to-
ruminant feed ban causes BSE prevalence to decrease. We noted that 
animal feed restrictions were implemented in the United Kingdom in 
1988, when the use of ruminant MBM in ruminant animal feed was banned. 
In September 1990, the use of specified bovine offals was banned for 
use in any animal feed. This ban prohibited the use in any animal feed 
of bovine tissues with the highest potential concentration of 
infectivity. In 1994, the use of mammalian protein--not just ruminant 
protein--was banned from ruminant feed. In 1996, feeding of any farmed 
livestock, including fish and horses, with mammalian MBM was completely 
banned. As a result of reducing the recycling of infectivity, the 
annual incidence of BSE fell by 99.4 percent, from 36,680 in 1992 to 
203 in 2005 (DEFRA 2006b). There is, therefore, every reason to expect 
downward pressure on the prevalence of BSE in any country that 
implements a feed ban.
    Issue: One commenter stated that, of 180,986 confirmed cases of BSE 
in Great Britain, the year of birth of the infected animal is unknown 
in 43,342 cases, and the large percentage of animals whose birth year 
is unknown casts doubt on the ability to determine the timeframe of an 
effective feed ban and, and further, makes it doubtful that all BSE-
infected cattle in Canada are going to show clinical signs of the 
disease only if they were born before March 1, 1999. The commenter also 
stated that Japan has reported cattle as young as possibly 20 months of 
age or younger as testing positive for BSE.
    Response: It is not clear to us how the information presented by 
the commenter supports the conclusions the commenter reached. However, 
we consider it useful to provide some clarification regarding the 
information presented. With regard to the proportion of BSE cases in 
Great Britain for which the date of birth is unknown, our risk 
assessment included a sensitivity analysis that takes into account that 
general source of uncertainty. (Sensitivity analysis evaluates the 
degree to which changes in the assumptions used in a model affect the 
model's results.) We made no assumptions as to whether Great Britain's 
feed ban is or has been effective, but applied the same proportional 
drop in cases observed in the United Kingdom to the Bayesian analysis 
that was performed to estimate BSE prevalence in Canada's standing 
cattle herd.
    The commenter's statement that it is doubtful that only animals 
born before March 1, 1999, would show clinical signs of BSE indicates a 
potential confusion between the likelihood of exposure as expressed in 
terms of the date of the effectively enforced feed ban (and, thus, the 
potential for exposure) and the likelihood of an exposed animal 
developing clinical signs (which is based on age and amount of 
exposure, and the amount of time that has elapsed since exposure). In 
neither our risk assessment nor our proposed rule do we conclude that 
only infected animals born before March 1, 1999, would show clinical 
signs of the disease. Based on Canada's system of regulations, 
compliance and enforcement, and the length of time we expect pre-feed 
ban feed to persist in the system, we conclude that animals born on or 
after March 1, 1999, have an extremely low likelihood of exposure to 
BSE. Any animal, however, exposed to an infectious dose of the BSE 
agent and allowed to live to the end of its incubation period, would 
likely exhibit clinical signs.
    Regarding the age of cattle diagnosed with BSE in Japan, the 
comment did not contain sufficient information for us to determine and 
respond to the relevance of the statement to the remainder of the 
comment.
    Issue: One commenter questioned the effectiveness of APHIS' use of 
United Kingdom surveillance numerators to estimate Canada's BSE 
prevalence. Specifically, the commenter stated that ``Nowhere * * * is 
incidence reported. Cases (without reference to a population at risk) 
are used. This may be important because the manner in which BSE cases 
were counted changed over time in the [United Kingdom].''
    Response: We acknowledge that changes over time in BSE surveillance 
and in the size and demographics of the cattle population do contribute 
to the uncertainty about the efficacy of the initial, ruminant-to-
ruminant feed ban introduced in the United Kingdom in 1998. However, 
the United Kingdom's Department for Environment, Food, and

[[Page 53325]]

Rural Affairs (DEFRA) does not report BSE surveillance results by birth 
year and surveillance class (e.g., active or passive surveillance, 
animal health status). Ideally, such data could be entered into BSurvE 
or a similar model to estimate true BSE prevalence for all United 
Kingdom birth year cohorts since the onset of the epidemic. This 
process would permit not only an improved estimate of the effect of the 
initial feed ban but also of the incremental impact of additional 
measures that were subsequently introduced. DEFRA has reported back-
calculation model estimates of true BSE prevalence in cohorts born 
after 1995 to assess the effects of the ``reinforced feed ban'' 
introduced by the United Kingdom in August 1996 (DEFRA 2005, 2006b). 
However, we are unaware of any published estimates of true BSE 
prevalence in the United Kingdom for the 1987-1995 birth year cohorts 
based on up-to-date surveillance results.
    Issue: One commenter stated that APHIS is wrong to assume that the 
United Kingdom data regarding the effectiveness of the feed ban can be 
applied directly to the situation in Canada.
    Response: We acknowledge that the applicability to Canada of the 
data from the initial United Kingdom ruminant-to-ruminant feed ban is 
uncertain. Nonetheless, the United Kingdom's experience and data are 
important and useful to our risk assessment and analyses. In addition, 
the Peer Review Report (RTI 2007, p. ES-2) noted that ``[all reviewers] 
agreed that the evidence from the United Kingdom * * * and Europe that 
the feed ban is effective is reasonable to consider in the case of 
Canada.''
    Issue: Several commenters noted the differences in the feed bans in 
the United Kingdom and Canada in stating that it is not valid to draw 
conclusions about the likely prevalence of BSE in Canada by 
extrapolating from the rate of decline in BSE cases in the United 
Kingdom following implementation of a feed ban there. The commenters 
noted that (until expanded this July) the feed ban in Canada prohibited 
the feeding of ruminant material to ruminants. In contrast, said one 
commenter, significant declines in the number of confirmed BSE cases in 
the United Kingdom did not occur until the United Kingdom took stronger 
measures, ultimately banning the feeding of all mammalian protein to 
food animals in 2001. The commenter suggested that the United Kingdom's 
experience in particular clearly shows that ruminant-to-ruminant feed 
bans do not drastically curtail the number of confirmed BSE cases and 
that much stronger measures are needed to eradicate the disease.
    Response: The comments appear to confuse the absolute level of BSE 
in the United Kingdom with its rate of decline. The comments also 
ignore the BSE incubation period and the effects of other concurrent 
measures, trends, and events in the United Kingdom. The number of BSE 
cases in United Kingdom birth year cohorts (all cattle born in a given 
year) has continued to decline since peaking in 1987. With the 
exception of the 1996 birth year cohort, it is not readily apparent 
that there has been any significant change in the rate of decline in 
birth year cohort prevalence after the United Kingdom introduced the 
initial ruminant-to-ruminant feed ban in 1988 (figure 2). As of March 
1, 2007, the United Kingdom had confirmed two BSE cases in animals born 
after 2001, but due to the long BSE incubation period, it is reasonable 
to expect that ongoing surveillance may detect additional cases in 
animals born after 1998.
[GRAPHIC] [TIFF OMITTED] TR18SE07.024


[[Page 53326]]


    Shortly after the emergence of vCJD was publicly recognized in 
March 1996, the United Kingdom introduced several BSE-related measures, 
including the ban on the use of mammalian MBM in feed for all farm 
animals (the ``reinforced feed ban''), a selective cull, and the over-
30-month rule limiting the age of animals that could be slaughtered for 
food. As shown in figure 3, the size of the United Kingdom cattle 
population began a marked decline in 1996, punctuated by a drop 
associated with the foot and mouth disease (FMD) outbreak in 2001.
[GRAPHIC] [TIFF OMITTED] TR18SE07.025

    In addition to the declining cattle population size, other 
confounding variables, such as changes in cattle population 
demographics and BSE surveillance practices, make it difficult to 
ascertain the independent or marginal effect of any single measure on 
the decline of BSE in United Kingdom birth year cohorts. At this time, 
it appears that the confluence of events and measures of 1996 may have 
hastened the waning of BSE in the United Kingdom, but the decline was 
underway in 1988.
    Issue: One commenter indicated that scientific studies in France 
and Britain have found that, after a ruminant-to-ruminant feed ban was 
put into place, the subsequent incidence of BSE was correlated to pig 
density, and that the new Canadian BSE feed rule, to be implemented in 
July 2007, is, according to the commenter, similar to, but weaker than, 
the September 1990 United Kingdom SBO [Specified Bovine Offals] ban. 
The commenter stated that, by not following the lead of the United 
Kingdom [and banning the feeding of all mammalian protein to food 
animals], the proposed CFIA SRM ban may reduce but will not eliminate 
the risk of BSE in Canada.
    Response: Two studies--Abrial et al. (2005) and Stevenson et al. 
(2005)--indicate a correlation between cases of BSE born after a 
ruminant-to-ruminant feed ban was implemented and areas of higher pig 
density in France and Britain. These studies indicate the potential for 
cross-contamination of livestock feeds after ruminant-derived protein 
was excluded from ruminant feed. Eventually, each country and the EU 
adopted regulations prohibiting the inclusion of any animal protein in 
livestock feed. At this time, however, it is not possible to ascertain 
the extent, if any, to which establishment of a more restrictive feed 
ban had any impact on the rate of BSE decline in EU Member States 
beyond the feed controls already in effect.
    As discussed previously, the number of BSE cases in United Kingdom 
birth year cohorts began to decline in 1988, the year the initial 
ruminant-to-ruminant feed ban was introduced. Although France initially 
introduced a ban on mammalian MBM in cattle feed in July 1990--not a 
ruminant-to-ruminant feed ban--the European Commission Scientific 
Steering Committee concluded that the French feed ban adopted in 1990 
``was likely not effectively enforced until 1994/1995.'' (ECSSC 2000, 
p. 30). Based on testing in 2001-2002, Bonnardiere et al. (2004) found 
a significant increase in French BSE prevalence between the July 1993-
June 1994 and July 1994-June 1995 cohorts, followed by a significant 
decrease in BSE prevalence in birth cohorts born in France after June 
1995. More recently, active surveillance during 2001-2005 also 
indicates that the number of BSE cases per cohort peaked in France in 
the 1995 birth year cohort and declined thereafter (EC 2006, table 
B20).
    In Europe more generally, based on active surveillance during 2001-
2005, the number of BSE cases per birth year cohort in the original EU 
Member States (EU 15), excluding the United Kingdom, was on the decline 
after the 1995 birth year cohort. In June 1994, the EU banned the 
feeding of mammalian MBM to ruminants. However, among EU members, only 
Belgium, Germany, Greece, Italy, Luxembourg, and Spain had no feed ban 
in place prior to the 1994 EU-wide measure (Court of Auditors 2001). In 
June 2005, the European Commission issued the ``Report on the 
Monitoring and Testing of Ruminants for the Presence of Transmissible 
Spongiform Encephalopathy in the EU in 2004'' and observed that the 
impact of the 2001 ``total feed ban'' (EU Regulation 999/2001) cannot 
yet be assessed due to the long BSE incubation period. As noted in the 
discussion of the decline of BSE in the United Kingdom, it is 
reasonable to expect that ongoing surveillance may detect additional 
cases in animals born after 1998.

[[Page 53327]]

    The conclusion of our risk assessment that, over the 20 years of 
the analysis, the risk to the United States (i.e., the likelihood of 
establishment and the potential impacts of cases that may occur even 
without establishment of BSE) as a result of importing from Canada the 
bovine commodities considered in this rule is negligible, is not 
predicated on the eradication of BSE in Canada.
[GRAPHIC] [TIFF OMITTED] TR18SE07.026

    Issue: One commenter indicated that year-of-birth data collected by 
the EU shows that, based on the number of BSE cases detected in the 
United Kingdom since 2001, there was a steady increase in the number of 
BSE-positive cattle born in the United Kingdom after its 1988 feed ban, 
beginning with cattle born in the year 1990.
    Response: We disagree with the commenter. Since July 2001, when the 
EU-wide active BSE surveillance program commenced, an increasing 
proportion of the total BSE cases in the United Kingdom have been 
detected as a result of targeted (active) surveillance (DEFRA 2006b, 
figure 4.3). However, as shown by the EC (EC 2006, chart B1), the vast 
majority of BSE cases in the United Kingdom were detected by 
surveillance prior to 2001. Based on all available United Kingdom BSE 
surveillance data (DEFRA 2007), the number of BSE cases in United 
Kingdom birth year cohorts began to decline in 1988, the year the 
initial ruminant-to-ruminant feed ban was introduced.
    For the reasons discussed above, we continue to consider it 
appropriate to apply our estimates of BSE prevalence in Canada to our 
risk assessment. As noted above, we used two related, but distinct, 
methods to estimate BSE prevalence in Canada, and addressed the 
uncertainty in the prevalence of BSE in Canada by considering 
prevalence estimates that differ by more than a factor of five. 
Although we consider the BSurvE Prevalence B estimate to be far more 
likely to be true than is the BBC estimate for the current standing 
Canadian cattle population, we consider the result of the BBC model as 
the more likely prevalence estimate to apply to the assessment of BSE 
risks associated with imports from Canada over the next 20 years.

Feed Ban in Canada

    As discussed above, in our January 2007 proposed rule, we proposed 
to allow the importation of live bovines from BSE minimal-risk regions 
if the animals were born on or after a date determined by APHIS to be 
the date on and after which a ruminant-to-ruminant feed ban in the 
region of export has been effectively enforced. We noted that 
experience around the world in countries with BSE has demonstrated that 
feed bans are effective control measures, and that the incidence of BSE 
worldwide continues to decline because of these measures (OIE 2007a).
    We indicated that, because of the demonstrated efficacy of an 
effectively enforced feed ban in reducing the possibility of exposure 
of cattle to the BSE agent, the OIE provides guidelines for trade in 
live cattle from regions that have reported BSE if such regions have an 
effective feed ban in place, provided the cattle were born after the 
date when the feed ban was effectively enforced (OIE Terrestrial Animal 
Health Code, Chapter 2.3.13). We proposed to consider March 1, 1999, as 
the date on and after which a feed ban has been effectively enforced in 
Canada. A number of commenters addressed Canadian enforcement of its 
feed ban, and also addressed the date we proposed to consider as the 
date of effective enforcement of a feed ban in Canada. Although some 
commenters specifically supported March 1, 1999, as the date of 
effective enforcement of a ruminant-to-ruminant feed ban in Canada, a 
number of other commenters disagreed that Canada was effectively 
enforcing a feed ban as of that date. Some commenters suggested 
alternative dates or time frames.
    Issue: Several commenters stated that APHIS' determinations of the 
level of compliance with the Canadian feed ban and the time at which 
compliance was achieved are arbitrary and scientifically 
indeterminable.
    Response: We disagree with the commenters. In January 2005, USDA 
sent a team to Canada to assess Canada's feed ban and its feed 
inspection program to determine whether the control measures put in 
place by the Canadian Government were achieving compliance with that 
country's regulations. APHIS conducted an extensive review of the feed 
ban in Canada. As part of its review, APHIS

[[Page 53328]]

analyzed CFIA's description of past cases of BSE in Canada, as well as 
historical inspection and compliance data related to the feed ban for 
the previous 3 years, educational materials, published notices, and the 
report of the International Review Team that was submitted to the U.S. 
Secretary of Agriculture in February 2004. Additionally, the U.S. team 
accompanied the CFIA inspection staff on inspections of randomly 
selected commercial feed mills and rendering facilities. At the 
facilities, the U.S. team observed the application of the inspection 
standards, observed manufacturing techniques, and discussed processes 
with facility personnel involved in various steps of feed 
manufacturing. In its report, the team concluded that Canada has a 
robust inspection program, that overall compliance with the feed ban in 
Canada is good, and that the feed ban is reducing the risk of 
transmission of BSE in the Canadian cattle population (USDA 2005). The 
team's findings support our conclusions regarding the level of 
compliance with the feed ban in Canada.
    Issue: In our January 2007 proposed rule, in discussing our 
rationale for considering March 1, 1999, to be the date of effective 
enforcement of a feed ban in Canada, we stated that a 12-month period 
would generally be sufficient to allow purchased feed products that may 
contain MBM to be completely used. One commenter expressed uncertainty 
about that estimation and suggested that it might be advisable for 
APHIS to conduct a quantitative assessment of compliance with the feed 
ban to determine the date of its effective enforcement.
    Response: We recognize uncertainty regarding the precise date on 
which Canada achieved effective enforcement of its feed ban, but we 
note that, given the extremely low prevalence of BSE in Canada along 
with the safeguards in the United States, the impact on the overall 
risk of a slightly earlier or later date would be minimal. Although 
reducing uncertainty can, at times, be achieved by performing more 
rigorous quantitative analyses, before attempting to reduce the 
uncertainty regarding any given factor or parameter--such as the 
precise date on which Canada achieved effective enforcement of its feed 
ban--it is important to examine the significance of the parameter to 
the overall risk result.
    Issue: Several commenters stated that APHIS' calculation of the 
amount of time necessary for ruminant feed to cycle through the 
Canadian feeding system is irrelevant in the absence of effective 
enforcement of feed-ban regulations in Canada. The commenters stated 
that it was not until between 2000 and 2002 that Canada implemented 
inspections of feed and rendering facilities.
    Response: The commenters' statement is not accurate. Inspections of 
rendering facilities and feed mills in Canada began immediately with 
the implementation of the feed ban in that country in August 1997. 
Rendering facilities were required to obtain an annual permit to 
operate, and issuance of a permit required an inspection of the 
facility. In addition, CFIA immediately began a program for inspection 
of commercial feed mills. All commercial feed mills were inspected in 
the first year after the implementation of the feed ban, with none of 
the feed mills found to be including prohibited material in ruminant 
feed. Thereafter, feed mills were on a 3-year inspection interval until 
2002, when annual inspection of commercial feed mills was initiated.
    Issue: A number of commenters stated that the diagnosis of BSE in 
cattle born after the establishment of a feed ban in Canada 
demonstrates that Canada's feed ban is either ineffective or not 
effectively enforced.
    Response: We disagree with the commenters' conclusion. The 
commenters suggest that, in order for the Canadian feed ban to be 
considered effective, BSE surveillance data would have to demonstrate 
that the likelihood of BSE transmission in that country has been 
eliminated. However, as noted in our risk assessment, Canadian BSE 
surveillance data do not provide a statistical basis for distinguishing 
BSE prevalence among birth year cohorts (APHIS 2006b, p. 12); the 
overall prevalence is so low that distinguishing any difference is 
nearly impossible. In other words, the data cannot distinguish any 
significant difference in prevalence among animals born in different 
years, which would have been one way to demonstrate the effect of a 
feed ban (e.g., if the feed ban were implemented at the beginning of 
1997, surveillance data showing a higher BSE prevalence in animals born 
in 1996 than in animals born in 1997 would support the effectiveness of 
the feed ban). However, in the absence of a feed ban that reduced 
exposure to BSE, we would expect the prevalence of the disease to 
increase over time. We have no evidence that such an increase has 
occurred, but we do have data that the feed ban is being enforced.
    Furthermore, as we discussed in our risk assessment, detection of 
BSE in an animal born after the date a feed ban was implemented does 
not indicate an overall failure of the measures in place to stem 
transmission of the disease in that country. Most other countries that 
have experienced cases of BSE, have reported similar cases. Of 25 
countries that have reported indigenous BSE cases, only 4 reported no 
cases in 2005-06 (OIE 2007). Human error is expected, which is why the 
feed ban is comprised of a number of interrelated measures that have a 
cumulative effect. Our risk assessment does not assume 100 percent 
compliance with all measures all of the time. We discussed factors 
related to the feed ban in Canada since before its implementation in 
1997. We considered activities related to inspection and compliance 
with the feed ban, the rendering industry, the risk of cross-
contamination, education activities and industry awareness, and on-farm 
practices that might contribute to the efficacy of the feed ban. In 
addition, we highlighted the fact that since the implementation of the 
feed ban on August 4, 1997, CFIA has continued to revise and strengthen 
its processes and procedures to further enhance the effectiveness of 
the feed ban. Canada's July 2007 modification of its feed ban to remove 
SRMs from all animal feeds, pet food, and fertilizer is a good example 
of such enhancements. We concluded that compliance with the feed ban 
measures in Canada continues to increase as the program evolves and 
that all of these factors have resulted in a cumulative reduction in 
the risk that Canadian cattle will be exposed to the BSE agent.
    Issue: Several commenters stated that Canada cannot demonstrate 
that it has effectively prevented the feeding of ruminant material to 
cattle over the past 8 years. Commenters stated that eight or nine 
Canadian feedlots were discovered to still be feeding banned bone meal 
products, and that, because of their violations of the feed ban, 30,000 
Canadian cattle were under quarantine. Additionally, one commenter 
stated that in March 2007, nine farms in Saskatchewan and as many as 
8,000 cattle, deer, and other ruminants were quarantined after ruminant 
MBM was accidentally shipped to those farms from a Saskatoon feed mill. 
Another commenter stated that, in December 2006, Canada's Minister of 
Agriculture and Agri-Food acknowledged that up to 10,000 head of 
Canadian cattle on 113 different farms in the Provinces of Ottawa and 
Quebec had recently been fed feed contaminated with ruminant material.
    Response: APHIS is aware of the incidents reported in late 2006 and 
in March 2007 and considered such incidences very carefully in its 
evaluation of the effectiveness of the

[[Page 53329]]

feed ban. However, it is not clear to us what the commenters are 
referring to regarding 30,000 Canadian cattle under quarantine.
    It should be noted that the use of the term ``contaminated'' above 
refers to the potential inclusion in ruminant feed of MBM derived from 
ruminants, but not to the feeding of known BSE-contaminated material to 
ruminants. Feed control systems, including those in the United States, 
are inherently subject to human error such as occurred in these 
incidents. These compliance errors require follow up and correction by 
CFIA, just as in the United States such incidents would necessitate 
follow-up by the U.S. Human Health and Services, Food and Drug 
Administration (FDA). Following detection of these occurrences, CFIA 
conducted a detailed investigation and traced all potentially 
contaminated feed. CFIA accounted for and disposed of all feed that did 
not enter the distribution channels, and feed already distributed to 
farms was removed, disposed of, and replaced. CFIA conducted risk 
assessments to help evaluate the possibility that new cases of BSE 
would occur due to the contamination of feed with prohibited material, 
and concluded that the overall risk was negligible. Even though this 
finding indicated that it was highly unlikely that animals exposed to 
the involved feed would develop BSE in the coming years, in those 
instances where exposure to the feed could not be ruled out, the CFIA 
has excluded these animals and their meat and byproducts from export 
eligibility. This measure was established to meet the technical 
requirements of various trading partners and does not affect the 
movement or marketing of these animals within Canada. These findings, 
together with Canada's rapid and comprehensive response to the 
incidents, reinforces our confidence in the effective enforcement of 
Canada's ruminant feed ban.\7\
---------------------------------------------------------------------------

    \7\ In the rulemaking for our 2005 final rule establishing 
criteria for recognition of a region as a BSE minimal-risk region, 
we discussed in detail our evaluation of Canada's veterinary 
infrastructure; disease history; practices for preventing widespread 
introduction, exposure, and/or establishment of BSE; and measures 
taken following detection of the disease (APHIS 2005).
---------------------------------------------------------------------------

    Issue: Some commenters questioned the effectiveness of Canada's 
feed ban, given evidence of contamination of ruminant feed with MBM 
derived from ruminants. One commenter stated that, in the five cases of 
cattle born after March 1, 1999, where investigations of BSE in 
Canadian cattle have been completed, the reported cause of BSE 
infectivity centered on ruminant MBM used in non-ruminant feeds cross-
contaminating ruminant feeds, either during processing at the feed mill 
or during transport. Given that four animals were born after March 1, 
1999, the commenters indicated that great care must be given to the 
analysis of these animals in the risk assessment and did not feel that 
APHIS thoroughly examined the cases.
    Response: We agree with the commenters that the investigations of 
BSE in animals born in Canada in 2000 and 2002 suggest that these 
animals were most likely exposed during their first year of life to 
feed contaminated during processing (CFIA 2006a). Reports of the 
investigations identified incidents of concern in which ruminant feed 
was processed or transported immediately following the handling of 
nonruminant feed containing prohibited material. Such incidents were in 
contravention of Canadian regulations, which require flushing and/or 
clean-out between batches if ruminant feed is processed on the same 
lines as feed containing prohibited material.
    We considered the issue of cross-contamination and concluded that 
Canada has implemented measures to prevent cross-contamination of 
ruminant feed with prohibited materials in the rendering and feed 
manufacturing industries are essential for implementation of an 
effective feed ban. We also considered other factors--including the 
regulatory actions taken to implement the feed ban, education and 
industry awareness efforts, inspection and compliance activities, and 
on-farm feeding practices--in our overall evaluation to determine the 
date the feed ban was effectively enforced in Canada and, based on 
those factors, identified March 1, 1999 as the date of effective 
enforcement of the feed ban.
    APHIS did not specifically address each individual case of BSE in 
Canada in the risk assessment, as the available details of each 
epidemiological investigation did not contribute to the overall risk 
estimation. The risk estimation was based on consideration of all 
factors relevant in the risk pathway. These included consideration of 
the current Canadian feed ban, with explicit recognition that cases 
born after the feed ban was implemented in August 1997, or after the 
March 1, 1999 date have occurred and could continue to occur. The 
prevalence estimate acknowledges that BSE is present in Canada, albeit 
at a very low level. The risk reduction factors in the United States, 
including feed ban regulatory activities similar to those in Canada, 
were considered in the exposure assessment. The combination of all of 
these factors, including recognition that human error can occur in any 
step of the pathway, supported the conclusion that the risk to the 
United States of BSE--i.e, the likelihood of establishment and the 
potential impact of cases that may occur even without establishment--as 
a result of importing from Canada the bovine commodities considered in 
this rule is negligible.
    Issue: One commenter stated that Canada has experienced an increase 
in the number of BSE cases since it instituted a feed ban in 1997.
    Response: It appears that the commenter is equating the number of 
detected cases of BSE with the number of infected animals in a national 
herd. However, an increased number of detections of BSE does not 
necessarily mean an increase in prevalence. A BSE detection rate is 
dependent not only on prevalence, but also on intensity of 
surveillance. An increased number of BSE cases have been detected in 
Canada as that country has increased surveillance for the disease. As 
noted above, an APHIS analysis of the Canadian BSE surveillance data 
did not find a statistical basis for distinguishing BSE prevalence 
among birth year cohorts.
    Issue: A number of commenters referred to the number of BSE cases 
in cattle born in Canada after March 1, 1999, as evidence that the date 
should not be accepted as the date of an effectively enforced feed ban. 
Commenters requested that APHIS reassess the proposed rule in light of 
recent diagnoses of such cattle.
    Response: In the assessment of potential BSE risk we conducted for 
this rulemaking, we concluded that there is an extremely low likelihood 
that cattle born in Canada on or after March 1, 1999, will have been 
exposed to BSE. This conclusion does not mean that effective 
enforcement necessarily equals no instances of contravention of the 
feed ban, either accidentally or intentionally, just as isolated 
transgressions of U.S. laws do not necessarily constitute ineffective 
enforcement of those laws.
    While specific incidents of cross-contamination can, and most 
likely will, happen, since no regulatory effort can ensure 100 percent 
compliance, the detection of BSE in several bovines in Canada born 
after March 1, 1999 does not negate the overall effect of the feed ban 
in decreasing the opportunities for transmission of disease. Empirical 
evidence from the United Kingdom has demonstrated, and simulation 
studies have reinforced, that implementation of a ruminant-to-ruminant 
feed ban leads to continued decrease in prevalence over time (Cohen, et 
al., 2001; 2003; DEFRA 2006, EC 2003; 2005). Similar

[[Page 53330]]

effects of a feed ban have been seen in other countries in the EU, 
where there have been continued detections of BSE in cattle born after 
a feed ban is initially implemented. At the same time, however, the 
apparent number of cases of BSE identified in the EU-15 Member States 
has decreased every year since 2001. The available evidence leads 
firmly to the conclusion that animals born after the date of 
implementation of a ruminant-to-ruminant feed ban are far less likely 
to be exposed to the BSE agent (Heim and Kihm, 2003).
    Issue: A number of commenters recommended various alternative dates 
or timeframes for consideration as the date of effective enforcement of 
a feed ban in Canada. Most of the commenters who recommended an 
alternative date expressed concern regarding the detection of BSE in 
bovines born in Canada after March 1, 1999.
    The recommended alternative dates or timeframes included the 
following: July 1, 2007; the date of birth of the youngest bovine in 
Canada that has been determined to be BSE-positive; May 1, 2002; 5 to 7 
years after the most recently diagnosed case of BSE in Canada; whenever 
Canada can verify 100 percent compliance with its ruminant-to-ruminant 
feed ban; a staggered system of dates that would increase the allowable 
age of bovines intended for importation from Canada as time progressed 
with no additional diagnoses of BSE in Canada.
    Some of the commenters who suggested July 2007 as the date of 
effective enforcement based their recommendation on the fact that on 
July 12, 2007, Canada expanded its feed ban to prohibit the inclusion 
of SRMs in any animal feeds, pet foods, or fertilizers. One commenter 
asked how APHIS can be satisfied that the United States would be 
importing a safe product if Canada itself was not satisfied with the 
safeguards in place at the time the proposed rule was published, and 
subsequently took additional measures to strengthen its feed ban. A 
number of commenters recommended that the provisions of the proposed 
rule not be implemented until Canada bans all feeding of animal 
material to food animals. One commenter stated that July 2007 would be 
an appropriate point to begin the importation of breeding animals that 
have had exposure to processed animal feed, and that March 1, 1999 
would be an acceptable date for bovines that have not been exposed to 
processed animal feeds--such as bison maintained by Parks Canada.
    Several commenters, who expressed no animal health concerns with 
identifying March 1, 1999 as the date of effective enforcement of a 
feed ban in Canada, recommended that APHIS consider harmonizing the 
date chosen with the date Canada has identified as the effective date 
of a ruminant-to-ruminant feed ban in the United States, January 1, 
1999.
    Response: In prior rulemaking (APHIS 2005), we evaluated evidence 
(regulations in place based on statutory authority, adequate 
infrastructure to implement the regulations, and evidence of 
implementation and monitoring) in making the determination that 
compliance with the feed ban in Canada is good and concluded that the 
feed ban was effectively enforced. In our process of identifying the 
date of effective enforcement of a ruminant-to-ruminant feed ban in 
Canada, we considered Canada's implementation guidance and policies. 
For example, we considered the allowance of grace periods for certain 
aspects of the industry, in determining the practical implementation 
period for the feed regulations. Then we considered a sufficient time 
period subsequent to this implementation period to allow most feed 
products to cycle through the system, given the management practices in 
the country. We concluded, based on the above evaluations, that cattle 
born in Canada on or after March 1, 1999, can be imported into the 
United States with an extremely low likelihood that they have been 
exposed to the BSE agent.
    As noted, a number of commenters recommended that APHIS consider 
July 2007, when Canada expanded its feed ban, as the date of effective 
enforcement of the Canadian feed ban. We consider the July 2007 
expansion of the Canadian feed ban to be an enhancement of an already 
effective ban. CFIA, in explaining its rationale for the enhanced ban, 
emphasizes that, although surveillance results and investigations of 
BSE cases indicate that the feed ban in Canada has effectively reduced 
the spread of BSE since being implemented in 1997, even compliance with 
the ban's requirements left limited opportunities for contamination 
during manufacture, transportation, and storage that CFIA considered 
worth eliminating. In addition, the accidental misuse of feed on farms 
with multiple species could not be discounted. With the enhanced ban, 
CFIA projects that the eradication of BSE in Canada will be 
accelerated. Following such a regulatory path does not indicate that 
the feed ban in Canada prior to July 2007 was not effective or 
effectively enforced.
    With regard to the recommendation that the date of effective 
enforcement of the Canadian feed ban be identified as the date of birth 
of the youngest bovine in Canada that has been determined to be BSE-
positive, we do not consider such a change to be necessary or 
justified. The risk assessment we conducted for this rulemaking 
acknowledged that BSE exists in Canada and that there would likely be 
additional cases detected. March 1, 1999 was never intended to be an 
absolute cut-off point after which no new cases of BSE would be 
acceptable. The risk assessment concluded that, despite the likelihood 
of additional diagnoses of BSE in Canadian cattle, the proposed 
amendments would pose negligible risk to animal health and food safety 
in the United States. If an infected cow were to be imported into the 
United States, a series of strong safeguards would have to fail--in 
sequence--for that animal to pose any risk.
    With regard to the recommendation that APHIS harmonize its 
identification of the effective enforcement date of a Canadian feed ban 
with the date identified by Canada as the date of effective enforcement 
in the United States, we do not agree that such a change would be 
appropriate or necessary. APHIS arrived at the March 1, 1999 date for 
effective enforcement of the feed ban in Canada by considering not only 
the date the feed ban was established in that country but also 
information provided by Canada regarding its implementation timetable, 
as well as feeding practices in that country. It does not necessarily 
follow that implementation events in the United States followed 
precisely the same track as those in Canada.
    Issue: In our January 2007 proposed rule, we discussed the 
diagnosis of BSE in cattle in Canada born after March 1, 1999, and 
stated that ``such isolated incidents are not epidemiologically 
significant and do not contribute to further spread of BSE, especially 
when considered in light of the entire risk pathway and its attendant 
risk mitigations.''
    Several commenters took issue with APHIS' description of the cases 
as ``isolated.'' Some commenters stated that ``isolated'' implies a 
solitary or separated condition, which cannot be said of the BSE cases 
recently confirmed in Canada. Further, other commenters stated the 
cases are linked by a trend in geographic location, with the last three 
cases occurring in the Province of Alberta. One commenter stated that 
of the nine cases of BSE detected in Canada, four occurred in cattle 
born after March 1, 1999, and that four of nine cases--or 44 percent--
do not represent isolated cases and strongly disagreed that this date 
corresponds to

[[Page 53331]]

when Canada's feed ban became effectively enforced.
    Response: We disagree with the comments, although we acknowledge 
that the term ``isolated'' could be interpreted in several ways. The 
use of the term in our proposed rule was not intended to imply that the 
cases were ``solitary or separated.'' Our use of the term ``isolated'' 
was intended to characterize the cases as being small in number and not 
indicative of a systemic failure of the feed ban in Canada, but rather 
the result of individual instances of error in contravention of the 
feed ban (e.g., inadequate cleaning between handling of feed for non-
ruminants and feed for ruminants).
    For the reasons discussed above, we consider our determination that 
March 1, 1999 be deemed the date of effective enforcement of the feed 
ban in Canada to be reasonable, grounded firmly in the regulatory basis 
and operations of the ban in Canada, and entirely consistent with the 
science and with OIE guidelines. Accordingly, we are making no changes 
based on the comments.

Likelihood of Exposure of Cattle in the United States to BSE

    The assessment is designed to estimate the likelihood of each of 
the multiple steps. Although we analyzed the likelihood of each 
individual step in the process occurring, we interpreted its 
significance in the context of the entire process.
    As part of the risk assessment we conducted for our January 2007 
proposed rule, we evaluated both the likelihood of ``release'' of the 
BSE agent into the United States and the likelihood of susceptible 
animals being exposed, given such release. We evaluated the pathways by 
which infected Canadian cattle, if imported, might expose U.S. cattle 
to BSE, and the likelihood that these pathways might lead to the 
establishment of the disease in the U.S. cattle population.
    Several steps must take place for BSE to be transmitted to cattle 
in the United States from a bovine imported live from another country. 
A BSE-infected bovine must be imported into the United States; the 
infected bovine must die or be slaughtered; tissues from that animal 
that contain the infectious agent must be sent to a rendering facility; 
the infectivity present in these tissues must survive inactivation in 
the rendering process; the resulting meat-and-bone meal (MBM) 
containing the abnormal prion protein must be incorporated into feed; 
and this feed must be fed to cattle at a level adequate to infect the 
cattle. (The amount of infectious material required in feed for cattle 
to become infected is dependent on the age of the cattle; younger 
cattle are more susceptible to BSE and require less BSE-contaminated 
feed to become infected (Arnold and Wilesmith, 2004). We indicated in 
our risk assessment that the nature and likelihood of these pathways 
depend in large part on mitigations acting in series and in parallel 
that reduce the likelihood that BSE will be established in the United 
States.
    A number of commenters addressed the issues of the likelihood of 
release of the BSE agent into the United States and the likelihood of 
exposure of U.S. cattle to BSE due to the importation of bovines from 
Canada. In general, the commenters said that we had underestimated the 
likelihood of release and/or exposure, or questioned one or more 
elements of our assessment.
    Issue: One commenter, whose statements were referenced and 
supported by a second commenter, discussed the geographic distribution 
of BSE cases in Canada and expressed concern that Canada's experience 
demonstrates that certain locations in the United States might be more 
susceptible to BSE establishment than others. The commenter stated that 
events in Canada indicate that an average risk estimate is meaningless 
for BSE and demonstrates how ``hot spots'' (i.e., locations that are 
more susceptible to spread of disease and, therefore, that have a 
localized higher BSE prevalence) allow BSE to propagate and spread. The 
commenter stated that the model-based predictions in APHIS' risk 
assessment are useless because the models do not account for geographic 
and other sources of heterogeneity and pointed to Alberta as a BSE hot 
spot. Further, the commenter indicated that the APHIS risk assessment 
has not provided any real data or relevant analyses related to BSE hot 
spot development and that APHIS has not quantified the risks that 
imports will create localized BSE hot spots in the United States. The 
commenter calculated that, if 5 percent of U.S. locations are potential 
hot spots, and 1 million animals are imported each year with six of 
them BSE-positive, the expected probability of at least one hot spot 
being activated in the United States is at least 77.7 percent.
    Response: We disagree with the commenters. The available evidence 
provides no basis for distinguishing BSE prevalence among Canadian 
provinces. The commenter who singled out Alberta provides no analysis 
to support the hypothesis that the BSE prevalence in Alberta is higher 
than in other provinces. Through May 2007, reported BSE cases have 
originated in three western Provinces: Alberta (8 cases), British 
Columbia (2 cases), and Manitoba (1 case). No cases have been reported 
through May 2007 in the eastern Provinces. Intuition might suggest that 
the BSE prevalence is higher in Alberta. However, Alberta contains 
approximately 40 percent of the Canadian cattle herd. Other factors 
being equal, BSE is more likely to be detected in regions with large 
cattle populations.
    Apart from the detected cases, geographically disaggregated data on 
BSE surveillance and Canadian cattle population demographics are not 
available. However, assuming that the total BSurvE points accumulated 
through August 15, 2006 (APHIS 2006c, table 4) were collected 
proportionally to the cattle population size in each province, table 3 
presents the allocation of the random sample size equivalents (BSurvE 
points).

                 Table 3.--Allocation of BSurvE Points among Provinces Proportional to Herd Size
----------------------------------------------------------------------------------------------------------------
                                                              Cattle                    BSurvE
                         Province                             (000)*      Percent       points     BSE  cases**
----------------------------------------------------------------------------------------------------------------
Alberta..................................................      6,300.0         38.8    594,858.4               7
Manitoba.................................................      1,720.0         10.6    162,405.8               1
British Columbia.........................................        830.0          5.1     78,370.2               1
Saskatchewan.............................................      3,450.0         21.2    325,755.8              0+
Ontario..................................................      2,203.9         13.6    208,096.6               0
Quebec...................................................      1,455.0          9.0    137,384.0               0
Nova Scotia..............................................        107.0          0.7     10,103.2               0
New Brunswick............................................         90.5          0.6      8,545.2               0
Prince Edward Island.....................................         84.5          0.5      7,978.7               0
Newfoundland.............................................          9.1          0.1  ...........  ..............

[[Page 53332]]

 
Labrador.................................................  ...........  ...........        859.2  ..............
                                                          ------------------------------------------------------
    Total................................................     16,250.0  ...........    1,534,357              9
----------------------------------------------------------------------------------------------------------------
*Source: Statistics Canada (2007).
**BSE cases reported through August 2006 were included in APHIS (2006c).
+The BSE case confirmed in May 2003 was born in Saskatchewan but reported in Alberta.

    Based on this allocation of evidence, a binomial likelihood ratio 
test (Fleiss et al., 2003) fails to reject the hypothesis that the 
provinces have the same BSE prevalence. That is, the result provides no 
basis for concluding that BSE prevalence varies among provinces. 
Depending on the method used to estimate provincial BSE prevalence, the 
test indicates that 11 to 20 BSE cases would have to have been observed 
in Alberta (or 4 to 7 cases in British Columbia) before rejection of 
the hypothesis.
    The commenters provide no data or analysis related to BSE hot-spot 
development. APHIS' risk assessment discusses the apparent geographic 
clustering of Canadian BSE cases reported through August 2006 in three 
western provinces: Alberta, British Columbia, and Manitoba (APHIS 
2006b, pp. 12-13). (In addition, the May 2003 case reported in Alberta 
was born in Saskatchewan.) However, APHIS also noted that the Manitoba 
BSE case was phenotypically different than the previously detected BSE 
cases of Canadian origin (APHIS 2006b). In addition, in its risk 
assessment, APHIS considered the CFIA report (CFIA 2006) that discusses 
geographic and temporal BSE clustering theories. APHIS concluded that 
the detection of further clusters (i.e., linked cases) that might be 
defined in the future cannot be ruled out and did not assume that any 
Canadian provinces are BSE-free. While BSE case investigations may 
reveal associations among individual cases, such as a common feed 
source, the question of clustering is scale dependent. At a local 
scale, there may be associations between individual cases, but at a 
regional or national scale, the clusters themselves may be 
geographically dispersed. In addition, the geographic disease dispersal 
pattern may change over time due to the movement of cattle.
    Further, the commenter provides no evidence or analysis to support 
the hypothesized sources of heterogeneity. On the contrary, 
disaggregating the available surveillance data into numerous strata to 
account for hypothetical sources of heterogeneity (geography, market 
class, etc.) generates substantial uncertainty within strata by 
diluting the sample size. One consequence of this practice (commonly 
called over-stratification) would be to inflate the upper confidence 
level risk estimates within putative strata (e.g., Alberta beef 
cattle).
    With regard to quantifying the likelihood of imports creating 
localized hot spots in the United States, the commenter provides no 
data or analysis, and cites no existing scientific literature, in 
support of the hypothesis that some U.S. cattle-producing areas are--on 
average--more susceptible than others to the establishment of BSE. 
While such spatial heterogeneity is theoretically plausible, APHIS is 
unaware of any empirical data that would provide a statistical basis 
for distinguishing BSE susceptibility among U.S. cattle-producing 
locations. Although the commenter claims that the APHIS analysis 
represents an average risk estimate, the assessment does consider 
random variability on the national scale in the BSE reproductive rate 
(R0) and the number of infected animals under each scenario 
or set of assumptions (APHIS 2006b). In essence, the commenter argues 
for a more disaggregated risk model that has random variability at the 
local level (in which regions are assumed to vary significantly from 
one another) rather than at the national level, but the comment does 
not provide any evidence in support of the hypothesis that such local 
differences (spatial heterogeneity) either exist, can be distinguished 
from a random distribution, or are of sufficient magnitude that they 
need to be accounted for by the model.
    Finally, the commenter's calculation of a 77.7 percent probability 
of at least one U.S. hot spot being activated rests on two assumptions. 
First, the commenter assumes that the prevalence of BSE in Canada 
exceeds the APHIS prevalence estimate by a factor of 10. There is no 
evidence to support this assumption. Second, the commenter assumes that 
there is a 5 percent probability that Canadian cattle would be 
introduced into pockets within the United States where R0 
exceeds unity. (If R0 exceeds unity (one), the disease will 
tend to spread. Conversely, if R0 is less than unity, the 
number of cases will tend to decline over time, and ultimately the 
disease will die out.) Other than asserting the existence of such 
pockets and that 5 percent of U.S. locations may be hot spots, the 
commenter provides no evidence to support this contention. Even if the 
comment did provide such evidence, it would have to show that in such 
pockets the value of R0 substantially exceeds 1 in order for there to 
be evidence that a substantial impact is likely. For example, if 
R0 = 1.1 and each generation of the disease (i.e., the time 
between infection of an animal and that animal's subsequent infection 
of another animal) lasts just 2 years, it would take 40 years for the 
disease prevalence to climb from 1 animal to 7. Finally, the 
commenter's suggestion supposes that no action would be taken to 
address vulnerabilities in a susceptible pocket if BSE did materialize. 
This assumption is inconsistent with APHIS' policy and record.
    Issue: One commenter asked whether the expected number of imported 
animals by class (i.e., the intended use of the animal, such as for 
breeding, immediate slaughter, or feeding and then slaughter) needed to 
be validated or explored in the sensitivity analysis.
    Response: We projected the expected number of imported animals by 
class because an animal's usage will govern at what age it goes to 
slaughter. How long a bovine lives will, in turn, have an effect on the 
animal's likelihood of developing detectable levels of BSE infectivity. 
The projected numbers of imports by age and use class used in our risk 
assessment were prepared for APHIS by USDA ERS. These values are based 
on USDA baseline projections, with specific factors considered based on 
the regulatory changes proposed. Additional details are provided in 
Appendix 1 of the Regulatory Impact Analysis and Final Regulatory 
Flexibility Analysis.

[[Page 53333]]

    Although these estimates cannot be entirely certain, they are based 
on the input of experts in the fields of commodity projection and 
cattle markets iteratively refined with estimates from widely accepted 
models. Therefore, alternative plausible assumptions for the number of 
imported animals by class would not likely vary substantially from 
those based on the most current inputs. Hence, the import projections 
do not contribute significantly to uncertainty in the total estimated 
rate at which BSE may be introduced into the United States from Canada. 
In any case, new economic information based on market forces and age 
verification described above indicates that, compared to those used in 
the published risk assessment, the import projections should be revised 
downwards, especially estimates for the projected number of older cull 
animals. As a result, any potential release of BSE-infected animals 
should be lower than previously estimated. In addition, the key 
determinant of the impact of an introduction of BSE into the United 
States is its propensity to spread within the cattle herd. The risk 
assessment results indicate that, because the reproductive constant, 
R0, remains consistently less than one, prevalence in the 
United States will tend to fall over time. (In order for the disease to 
spread, R0 must exceed unity (one).)
    Issue: One commenter stated that the incidence rate among just the 
older cattle covered by the proposed rule would be expected to be even 
higher than the overall incidence for all Canadian cattle slaughtered, 
thereby making the likely risk even greater.
    Response: We are not certain what the commenter is referencing as 
``overall incidence for all Canadian cattle slaughtered.'' We note that 
APHIS estimated the prevalence of BSE in the standing adult cattle 
population in Canada, not the BSE incidence in all Canadian cattle 
slaughtered. The Canadian BSE surveillance data provide no statistical 
basis for concluding that one birth-year cohort has a higher or lower 
BSE prevalence than another. Therefore, we assumed for our risk 
assessment that all animals in the current standing Canadian cattle 
population, including animals 30 months of age and older that are 
eligible for importation under this rule (as well animals that are not 
eligible for importation under this rule due to the birth-date 
requirement) have the same probability of BSE infection. However, it 
would not be surprising if animals born at an earlier date (i.e., 
either before or around the time the feed ban was implemented) have a 
greater likelihood of exposure to contaminated feed, and therefore 
could have a higher prevalence of BSE than animals born in later years. 
For this reason, we are restricting imports of live bovines from Canada 
to those born after the date when the country had an effectively 
enforced feed ban--which we have determined to be March 1, 1999. 
Additionally, of the live bovines we project will be imported following 
the effective date of this rule, greater than 80 percent of the animals 
are expected to be younger than 2 years of age at the time of 
importation.\8\ Therefore, even if older animals had some significantly 
higher level of BSE prevalence (which is already reflected in the 
standing herd estimates), the fact that this rule excludes the 
importation from Canada of bovines born before March 1, 1999, along 
with the fact that the large majority of animals are expected to be 
young, would tend to decrease, rather than increase the overall risk 
from that which we have estimated.
---------------------------------------------------------------------------

    \8\ As discussed in the regulatory impact analysis APHIS 
conducted for this rule, most steers and heifers are ready for 
slaughter between 16 and 24 months of age, feeders are generally 
ready between 9 and 15 months of age, and vealers and light calves 
are slaughtered between less than 3 months and 8 months of age. In 
our analysis, we project that the total number of projected imports 
from Canada for these three categories of cattle in 2008 will be 
987,000. This represents about 88 percent of the overall number of 
cattle projected to be imported from Canada in 2008. This percentage 
does not include imported replacement heifers and other breeding 
stock younger than 2 years of age.
---------------------------------------------------------------------------

    Issue: One commenter indicated that Canada's BSE prevalence rate 
essentially guarantees (probability greater than 98 percent) that some 
BSE-positive cattle will enter the United States. Another commenter 
suggested that there is a 99.75 percent chance that one or more cattle 
that would test positive for BSE will be imported into the United 
States among the first million cattle that would be imported after 
adoption of the proposed rule.
    Response: We note that prevalence refers to the proportion of BSE-
infected animals, not the proportion of animals that would test 
positive for BSE. BSE-infected cattle are unlikely to test positive 
unless they are tested at a late stage of disease incubation.
    Nevertheless, the commenter's estimated likelihood of entry of BSE-
infected cattle is consistent with the APHIS risk assessment. The risk 
assessment clearly acknowledged the possibility of importing infected 
animals. Given the estimated current prevalence in Canada, table 7 in 
the risk assessment presents the projections for imports in the first 
year of implementation, including infected animals.
    Issue: One commenter expressed doubt regarding the conclusion 
reached by the APHIS risk assessment that--because Canada's BSE 
prevalence will likely decrease over time, and because of the barriers 
to BSE transmission in the United States--the likelihood of BSE 
exposure and establishment in the U.S. cattle population as a 
consequence of the proposed rule is negligible. The commenter stated 
that the overlapping safeguarding measures described in the risk 
assessment have not prevented the continued spread of BSE in other 
countries (including Canada) that have relied on similar measures. The 
commenter further suggested that the measures have not been empirically 
tested or validated and cited the four Canadian BSE cases born in the 
years 2000 and 2002 as evidence that the measures are, in fact, 
ineffective to either reduce or prevent BSE infection.
    Response: We disagree with the commenter's statements. Various 
data--epidemiological, modeling, and experimental--clearly demonstrate 
that the barriers discussed in the risk assessment and the proposed 
rule will decrease the risk of the introduction of BSE and its 
amplification. These barriers have been used internationally as 
strategies for the control and prevention of BSE. Furthermore, the 
barriers have demonstrated a striking effect in curtailing the epidemic 
and are responsible for the downward pressure on the prevalence of BSE 
observed in the United Kingdom and Europe. As described in the risk 
assessment: (1) Slaughter controls prevent the recycling of infectivity 
into human food and cattle feed; (2) rendering processes contribute to 
the inactivation of the BSE agent; and (3) feed controls prevent the 
recycling into cattle feed. In addition, there is epidemiological 
evidence of an age-related susceptibility to infection, which implies 
that the animal not only needs to be exposed to the BSE agent to become 
infected, but needs to be exposed with a sufficient dose at the time in 
its life that it is susceptible. For disease transmission to occur, the 
following events must happen in sequence: An infected animal dies or is 
slaughtered at a sufficiently late point in the incubation period to 
have significant infectivity present in certain tissues; those tissues 
go into the rendering system; some level of infectivity remains after 
the rendering process; the resulting protein is included in feed; and 
feed is fed to a ruminant in a sufficient amount at an age when it is 
susceptible. Although this could occur, the likelihood of it happening

[[Page 53334]]

repeatedly is negligible. This fact is demonstrated in the quantitative 
exposure model used in our risk assessment--i.e., transmission can 
occur, but it is not sufficient to sustain the disease (R0 
remains far less than one).
    We reviewed Canada's feed production process (e.g., regulations in 
place based on statutory authority, infrastructure to implement the 
regulations, and compliance with the regulations). We used a peer-
reviewed model to estimate the prevalence and determined that the 
prevalence in Canada is extremely low. We also used a peer-reviewed 
exposure model in our assessment of the risk (Cohen et al., 2001; 
2003). This model takes into consideration several parameter values 
that are based on experimental and epidemiological information related 
to BSE. These parameters represent key epidemiological elements related 
to the mechanisms by which BSE is transmitted. As we indicate in the 
exposure assessment, that assessment demonstrated that, because we 
expect Canada's prevalence to decrease over time, and because of the 
barriers to BSE transmission in the United States, the likelihood of 
BSE establishment in the U.S. cattle population is negligible. We reach 
the same conclusion even without assuming a drop in Canada's BSE 
prevalence over the next 20 years.
    Issue: One commenter, in addressing risk mitigation measures in 
place in the United States, stated that several loopholes remain in the 
U.S. feed ban through which BSE infectivity could be introduced to 
cattle, despite recommendations from an APHIS TSE Working Group.
    Response: APHIS has proceeded in a thorough and deliberative 
manner, in cooperation with FSIS and FDA, to determine the steps 
necessary to continue to protect animal and public health. APHIS has 
used a peer-reviewed model to assess the likelihood of exposure of 
cattle to BSE as a result of importing live cattle from Canada under 
the proposed rule (Cohen et al., 2001; 2003). This model takes into 
consideration several parameter values relevant to the cattle 
production process, including what the commenter refers to as loopholes 
in the feed ban regulations. Even after considering these features of 
the U.S. system, the results indicate that the likelihood of BSE 
exposure and establishment in the U.S. cattle population as a 
consequence of infectivity introduced via imports from Canada is 
negligible.
    Issue: One commenter stated that the models that Canada and the 
United States used in estimating BSE risk are not validated and have no 
predictive value. The commenter stated further that the predicted risks 
from the Harvard model would increase almost 15-fold if compliance is 
less than assumed in the base case.
    Response: We disagree with the commenter's assessment of the 
quantitative exposure model we used in developing our risk assessment. 
As noted earlier, the plausibility of the model was established by 
comparing its predictions for Switzerland against the observed 
progression of BSE within that country's cattle herd (Cohen et al., 
2003). Although the model's performance in the United States has not 
been empirically evaluated (because there have been too few cases in 
the United States to do so), the use of models to characterize future 
risks is well-accepted in the scientific community.
    The commenter cites an FSIS risk assessment (Cohen and Gray, 2005), 
which uses a version of the Harvard model, to argue that, if the 
misfeeding rate parameter is highly uncertain, the resulting range of 
results generated by the simulation model is likewise wide. As 
explained in the APHIS risk assessment, new information indicates that 
the original range of estimates for the misfeeding rate in the Harvard 
model as originally developed in 2001 were overly pessimistic. APHIS 
obtained new data and, using these new data in the Harvard model, 
reduced the range of the original estimates. Therefore, in APHIS' 
evaluation, the impact of misfeeding on the output of the model is much 
more modest.
    Issue: One commenter asserted that APHIS' risk assessment model 
predicts low or ``negligible'' risks only if optimistic assumptions are 
made.
    Response: APHIS disagrees with the commenter. The commenter simply 
cites the results of APHIS' own sensitivity analysis using 
``pessimistic'' assumptions and provides no evidence or analysis 
demonstrating that the APHIS ``base case scenario'' assumptions are 
optimistic. APHIS combined qualitative and quantitative methods in its 
assessment of risk from live cattle. We qualitatively evaluated what we 
expect as the most likely scenario--prevalence drops in Canada over the 
next 20 years, resulting in decreases in potential release and 
exposure. While the commenter may consider this expectation an 
optimistic assumption, we do not and we note that this assumption is 
based on evidence from countries around the world that a feed ban 
provides continuous downward pressure on prevalence.
    However, APHIS also considered other less likely (more pessimistic) 
scenarios, for which we assumed that the prevalence in Canada remained 
constant over the next 20 years, using a quantitative exposure model. 
The quantitative exposure model simulates the cattle management system 
in the United States, with assumptions made for certain variables, or 
parameters as input to this system. These parameters include BSE 
prevalence in Canada, which is an exogenous variable (and therefore, 
external to the U.S. system of mitigations), and many endogenous, or 
internal parameters. The endogenous parameters include various aspects 
of compliance with the FDA feed ban, how many carcasses enter the 
rendering system, what rendering processes are used, how rendered 
protein is incorporated into feed, and many other factors that can 
contribute to the spread of BSE. The values for each of these 
parameters basic assumptions that are meant to represent the most 
plausible and realistic representation of the U.S. system are reflected 
in the ``base case scenario.''
    Assumptions regarding those parameters for which we have the least 
information (or the most uncertainty) were changed to more pessimistic, 
but still plausible, values in the sensitivity analysis, to evaluate 
the degree to which these changes would affect the results as compared 
to the base case. Given that at least one significant parameter--the 
constant prevalence of disease in Canada--was pessimistic even in the 
base case, we do not agree with the commenter's assertion that the 
quantitative model predicts low or negligible risk only if optimistic 
assumptions are used. Moreover, even under the more pessimistic 
scenario examined in the senstivity analysis, the reproductive rate of 
BSE (R0) remains far below 1, indicating that the disease 
would not become established in the United States.
    Issue: Several commenters stated that APHIS has not adequately 
considered the risk that imperfect compliance with U.S. SRM removal 
policies would have once we allow the importation of cattle over 30 
months of age from Canada. One of the commenters stated further that 
APHIS provided no data or analysis in the proposed rule to address this 
series of known incidences of noncompliance.
    Response: We disagree with the commenters. As noted in our risk 
assessment, the quantitative exposure model assumes that SRMs are 
effectively removed 99 percent of the time. This assumption is based on 
FSIS summaries of Noncompliance Records (NRs) performed from January 
2004 to

[[Page 53335]]

May 2005 in about 6,000 federally inspected meat and poultry 
establishments. Based on these records, FSIS estimated that 
noncompliance with respect to SRM-related regulations had a frequency 
of less than 1 percent.
    To explore the possible impact of assuming an arbitrary decrease 
(compared to the results of our exposure model) in SRM removal 
compliance on the availability of infectivity for human consumption, we 
can discuss the significance of an order of magnitude increase in 
available infectivity compared to our model's findings. First, we 
consider the results of that model, which used the unlikely assumption 
that prevalence in Canada (and thus the proportion of infected animals 
imported from Canada) remained constant over the next 20 years. In the 
model's scenario, the total amount of infectivity potentially available 
for human consumption over the 20 years of the analysis is 45 cattle 
oral infectious dose-50 units (ID50s). (BSE infectivity is 
expressed in terms of cattle oral ID50s. A cattle oral 
ID50 is defined as the amount of infectivity required to 
cause infection in 50 percent of an exposed cattle population (APHIS 
2006)). The significance of cattle oral ID50 units to human 
exposure and susceptibility is not known; however, various studies 
suggest that the infectious agent may be 10 to 10,000 times less 
pathogenic in humans than in cattle because of a species barrier (EC 
SSC, 2000). Thus, if the cattle--human species barrier were 100, it 
would mean that 100 times more infective material would be required in 
order to have a similar probability of infecting a human as a bovine. 
Comer and Huntly (2003) estimated, after an evaluation of available 
literature, that 54 million bovine oral ID50 units were 
available for human consumption in Great Britain from 1980 to 2003. 
This extremely large amount of available infectivity has resulted in 
165 cases of vCJD identified in the United Kingdom through April 2007, 
plus a few additional cases identified in other countries but 
attributed to exposure in the United Kingdom. When compared to the 
United Kingdom's BSE experience and the associated estimate of 
available bovine oral ID50 units, the expected, or average 
value of 45 cattle oral ID50 indicates that only a miniscule 
amount of the BSE infective agent that could possibly be available for 
potential human exposure in the United States over a 20-year period 
(APHIS 2006). (The potential for human exposure under this scenario is 
estimated at 1,200,000 times less in the United States than what the 
United Kingdom experienced during its BSE epidemic.) Even if compliance 
with the SRM ban were not as high as the 99 percent estimated in our 
exposure model, and we were to assume that the infectivity available 
for human consumption were increased by an order of magnitude (10x), it 
would still be far less than that estimated to have circulated in the 
United Kingdom and, we conclude, not to be of significance to human 
health.
    Issue: One commenter stated that, although APHIS assumes that 
removal of SRMs from a bovine carcass will effectively shield consumers 
from exposure to BSE, numerous studies have demonstrated limitations on 
mitigating the risk of BSE exposure via SRM removal. In particular, the 
commenter stated that APHIS did not appropriately consider several 
studies (Buschmann, 2005; Iwamaru et al., 2005; Hoffman, 2006) related 
to the distribution of SRMs, and that APHIS failed to explain why these 
uncertainties and concerns do not undermine its almost exclusive 
reliance on SRM removal requirements to protect American public health 
from potentially hazardous Canadian imports.
    Response: We are aware of the studies cited by the commenter and do 
not agree that they question the efficacy of SRM removal. We 
acknowledge that studies using new methods that provide increased 
sensitivity will probably demonstrate the presence of PrP\BSE\ (the 
abnormal form of the prion protein) in various tissues. However, 
demonstrating the presence of PrP\BSE\ does not necessarily indicate 
the presence of BSE infectivity, especially if no infectivity is 
demonstrated via the most sensitive method available: Cattle-to-cattle 
exposure via intracerebral transmission. Therefore, one cannot 
automatically assume that a finding of PrP\BSE\ in a tissue means the 
tissue should be defined as an SRM. The OIE made this particular point 
in the Terrestrial Animal Health Standards Commission Report, October 
2006--Supporting Document for Chapter 2.3.13. Of the Terrestrial Animal 
Health Code on Bovine Spongiform Encephalopathy, as follows:

    The availability of experimental infectivity data has 
significantly increased in recent years. During the same interval, 
extremely sensitive tests have been developed, including those 
employing highly sensitive transgenic mice strains and potentially 
more sensitive laboratory PrP detection methods. With the 
development of such highly sensitive methods, the probability of 
detection of PrP\BSE\ in tissues that are not currently listed as 
infectious is increasing. However, such findings need to be 
considered in context, and their relevance to establishing risk to 
consumers evaluated carefully when the quantity of PrP\BSE\ detected 
is potentially below the limit of detection of intracerebral (i.c.) 
cattle to cattle bioassay. By April 2007, 165 variant Creutzfeldt-
Jakob Disease (vCJD) cases had been detected in the United Kingdom, 
a country where most probably the majority of the population was 
exposed to the BSE-agent. The latest models of the vCJD epidemic 
estimate that the potential scale of the clinical epidemic arising 
from food-borne exposure is unlikely to exceed 400 future cases in 
the United Kingdom (Clarke and Ghani, 2005). The relatively low 
number of predicted vCJD cases in relation to the massive exposure 
to the BSE agent is suggested to be due mainly to a significant 
species barrier between cattle and humans (Comer and Huntley, 2004; 
Bishop et al., 2006).

    APHIS is familiar with the results of the study (Buschmann, 2005) 
cited by the commenter in which tissues from a BSE-diseased cow were 
inoculated into genetically engineered (transgenic) mice that are 
highly susceptible to BSE and which over-express the bovine prion 
protein. Using this extremely sensitive mouse assay, this study 
demonstrated low levels of infectivity in the peripheral nervous system 
(e.g., facial and sciatic nerves) of the infected cow. APHIS discussed 
these findings in its risk assessment and concluded that ``[g]iven all 
these factors there is not sufficient information to alter our 
understanding of the epidemiologically significant distribution of BSE 
infectivity in cattle.'' APHIS also acknowledges the results of 
Japanese studies in which PrPBSE has been reported in the 
peripheral nerves of a case of BSE (Iwamaru et al., 2005) and in some 
peripheral nerves of cattle slaughtered at abattoirs in Japan (Iwata et 
al., 2006) by Western blot analyses. APHIS has also reviewed the German 
study in which infectivity was detected in the brainstem of an animal 
at 24 months post-infection (Hoffman, 2006). We have carefully 
considered all of these findings. USDA reviews and takes into 
consideration all BSE research for the definitions of SRMs, as does 
Canada and other countries internationally. As noted in the quote 
above, international policies regarding SRM removal have not changed 
based on the results of the studies discussed. Both the U.S. and 
Canadian policies regarding SRM removal are consistent with 
international standards.
    Issue: One commenter referenced an FSIS study that found that the 
removal of SRMs can reduce human exposure to BSE by about 80 percent. 
The commenter stated that this level of protection is clearly 
inadequate to protect the United States from risks associated with the 
importation of older

[[Page 53336]]

cattle from Canada that represent an inherently higher risk for BSE. 
The commenter then referred to the sensitivity analysis APHIS conducted 
as part of its risk assessment, which incorporated a higher value for 
Canada's BSE prevalence than in the more likely base-case scenario. The 
commenter expressed concern that the sensitivity analysis revealed that 
108 BSE infected cattle could be imported into the United States over 
the next 20 years and result in 12 new BSE cases in the United States.
    Response: We disagree with the commenter regarding the significance 
and applicability of the cited study. In this response, we present a 
more appropriate study from which to draw useful inferences regarding 
the impacts of SRM removal.
    The 2004 FSIS document referred to by the commenter--Preliminary 
Analysis of Interim Final Rules and An Interpretive Rule to Prevent the 
BSE Agent From Entering the U.S. Food Supply''--is an analysis intended 
to evaluate the major impacts of measures contained in the FSIS interim 
final rules published and implemented in January 2004. FSIS used the 
Harvard model in this analysis to estimate the benefits of these 
measures, specifically ``those [benefits] resulting from the reduction 
in human exposure to BSE infectivity.'' FSIS used this model to create 
a baseline estimate of potential human exposure and then evaluated 
three scenarios of risk mitigation options (e.g., SRM removal) for 
comparison to the baseline. In each simulation, FSIS assumed that five 
infected animals were introduced into the United States in 2003, and 
then simulated the spread of BSE infectivity until 2020. The 
simulations of the risk mitigation measures were run assuming that the 
mitigations were implemented in 2004, i.e., approximately 12 months 
after the introduction of infected animals. While the commenter is 
correct that this analysis demonstrated a reduction in potential human 
exposure of 80 percent, the comment does not accurately portray the 
context of this result. Given the assumptions used in the simulation 
(i.e., the risk mitigation measures, including SRM removal, were not 
implemented until 12 months after introduction of infectivity), a 
certain amount of infectivity would have become available for human 
exposure before the mitigations measures were implemented in the model 
scenario. Therefore, the mitigation measures could never eliminate all 
of the infectivity available. Since all scenarios included at least 
some time in which the mitigations were not implemented, under the 
simulations, a certain amount of potential infectivity was allowed into 
inappropriate channels, such as human food. Because none of these 
scenarios incorporated the more realistic assumption that the 
mitigations were implemented (even imperfectly) throughout the 
simulation period, it is inappropriate to use this analysis as a 
citation for the level of public health protection provided by risk 
mitigation measures in place in the United States.
    A more appropriate analysis for understanding the role of SRM 
removal in potential human exposure to BSE infectivity would be the 
FSIS update of the same Harvard simulation model that was available for 
public comment in 2006. APHIS cites the analysis in the risk assessment 
conducted for this rulemaking as Cohen and Gray (2005). This updated 
model used the ``base case'' as the circumstances in the United States 
prior to December 2003, and simulated the response of the U.S. system 
for 20 years following the import of BSE-infected cattle. FSIS' updated 
model estimated the impact of various risk management measures, 
including measures that were adopted, considered, or proposed by 
various agencies and groups. These simulations, where the risk 
mitigation was applied during the entire simulation, as opposed to the 
simulation in the analysis cited by the commenter (in which it was 
not), indicated that removing SRMs, as currently defined by FSIS, 
reduced potential human exposure by more than 99 percent, on average. 
This report also stated that ``[i]t is worth noting that these measures 
reduce what is already a small exposure in absolute terms.''
    Issue: One commenter stated that SRM removal requirements have not 
been in place long enough for an effect to be determined, due to the 
exceedingly long incubation periods assumed for humans. The commenter 
stated further that the experience of other countries in which BSE has 
been detected (except for Canada) cannot be used to demonstrate that 
SRM removal is highly effective, because other countries have more 
stringent SRM removal requirements than do Canada and the United States 
and their experience is not applicable for predicting risk in the 
United States.
    Response: The commenter appears to be questioning two points--
first, whether SRM removal is actually highly effective in protecting 
public health, and second, whether experience in Europe can be used as 
a comparison for expectations in North America.
    The commenter is correct in that there has been no specific 
controlled study that clearly and unequivocally demonstrates the 
effectiveness of SRM restrictions on protecting public health. The 
absence of such a study does not negate the fact, however, that 
substantial epidemiological and case evidence clearly indicate the 
success of such control measures. It is widely and generally accepted 
internationally, including by such international bodies such as the 
World Health Organization (WHO) and the OIE, that the primary public 
health protective measure regarding BSE is the removal of SRMs from the 
human food supply (WHO, 2002).
    The OIE Scientific Revue notes the following: ``Excluding SRM from 
the human food chain effectively minimizes the risk of human exposure 
and is the most important measure taken to protect consumers. Failure 
to remove SRMs would probably expose a large number of consumers to an 
unnecessary risk.'' (Heim and Kihm, 2003). This point is also widely 
acknowledged in scientific literature, including articles cited by the 
commenter. For example, Bradley and Liberski (2004) conclude that 
``risks to humans from infected cattle are now remote so long as the 
[bans on the use of SRMs in human food] are rigorously enforced.'' Fox 
and Peterson (2004) conclude that ``[a]doption of the human [specified 
bovine offal] ban in the United Kingdom in 1989 is probably the only 
example in the BSE story of a government going beyond expert opinion in 
taking a precautionary measure. It turned out to be the correct 
decision, and likely saved thousands of people from exposure to the 
disease.''
    Simulation models and analysis conducted in the United Kingdom 
support the assumption that primary exposure sources for people were 
SRMs in the food supply prior to imposed restrictions. These models 
have been updated and revised repeatedly since the original 
identification of vCJD and the link to BSE in cattle (Ghani and others, 
1998, 2000, 2001, 2003, 2005). They incorporate assumptions for all the 
parameters that could influence the course of vCJD in the United 
Kingdom--including assumptions about primary exposure from dietary 
sources, calculations about how many infected cattle may have been 
slaughtered at different points in time, what tissues from those 
animals were available for consumption, and what restrictions were 
imposed on the tissues and types of products available for consumption. 
The models are updated routinely to incorporate new information about 
vCJD cases as they are reported.
    These models have been used to predict the course of the vCJD 
epidemic in the United Kingdom. Initially, the

[[Page 53337]]

projections were fairly high with considerable uncertainty. As more 
information is incorporated into the models, these projections continue 
to decline and the uncertainty levels also decrease. The number of 
clinical cases of vCJD in the United Kingdom has continued to decline 
since an apparent peak in 2000 (Andrews, 2007). This decline is 
consistent with projections made from the models, thus validating some 
of the assumptions used in the models. As an example, Cooper and Bird 
(2003) assume that the primary sources of exposure are the consumption 
of meat products--including mechanically separated meat and head meat--
that were most likely contaminated with SRMs such as spinal cord, 
dorsal root ganglia, and brain. Restrictions on the inclusion of spinal 
cord and brain, among other tissues, were initially imposed in the 
United Kingdom in 1989. Restrictions on the production of mechanically 
separated meat, which included a significant level of infectivity from 
dorsal root ganglia, were imposed in the United Kingdom in 1995. Cooper 
and Bird (2003) concluded that ``[t]here is remarkable similarity 
between the age distribution and gender of simulated and observed vCJD 
patients, which supports (but does not prove) our assumption about the 
primary sources of exposure to BSE.''
    The commenter notes the ``exceedingly long incubation periods 
assumed for humans.'' More recent updates of the models described 
previously have included estimates of the mean incubation period for 
vCJD (Ghani et al., 2003) and estimated the mean incubation period for 
vCJD at 12.6 years when using the accumulated case data from confirmed 
vCJD cases. When additional information was added from results of a 
screening study performed on appendix and tonsil tissues, the mean 
incubation period was 16.7 years when fitted to this data. From this 
evidence, we can conclude that even the longer mean incubation period 
of 16.7 years would allow sufficient time to demonstrate the effect of 
SRM restrictions on the outbreak, since the initial SRM restrictions 
were imposed in 1989. We note that all vCJD cases that have been 
genotyped to date, with one exception, have been of the homozygous 
methionine (MM) genotype at codon 129 of the human prion protein gene. 
It is estimated that approximately 40 percent of the Caucasian 
population is homozygous methionine, with approximately 10 percent 
valine homozygous, and the remaining 50 percent heterozygous. While the 
effect of genotype on vCJD is still unknown, we can evaluate scenarios 
in the MM genotype as an example of epidemic progression, because this 
genotype may be the most susceptible and/or have shorter incubation 
periods than other genotypes.
    The second point the commenter raises is whether there would be 
significant differences in potential public health exposure due to the 
different definitions of SRMs in Europe and North America (Canada and 
the United States). While these definitions identify essentially the 
same tissues, European regulations define tissues such as brain and 
spinal cord as SRMs in animals greater than 12 months of age, where 
North American regulations define these tissues as SRMs in animals 
greater than 30 months of age.
    In the past few years, significant consideration has been given to 
the age limits on SRMs and their appropriateness. Additional 
information obtained from new research findings has contributed to 
these evaluations. Scientists in Europe have specifically examined 
these findings as part of their consideration on the age limit in 
cattle for the removal of SRMs (EFSA, 2005; 2007). In each of these 
opinions, they conclude that any likely detectable infectivity in the 
central nervous system (CNS)--including the SRMs in question--appears 
at about 75 percent of the incubation time. These opinions also note 
that the experimental low-dose scenarios are more likely to resemble 
the actual field exposure. The low-dose research scenarios are those in 
which calves were exposed orally to 1 gram of highly infective brain 
tissue, rather than the 100 grams used in the high-dose scenario. 
Experimental attack rate studies indicate that the incubation period 
for the low-dose scenario has a mean of 60 months, with a range of 45 
to 73 months (Wells et al., 2007). Using the low end of this range of 
incubation period, and assuming that infectivity is present in the CNS 
at 75 percent of the incubation period, they predict that infectivity 
would be sub-detectable or still absent in CNS in cattle aged 33 
months.
    In the United Kingdom, even including cases from the height of the 
BSE epidemic there, which are believed to have had shorter incubation 
periods than more recent cases, the peak age at onset of clinical signs 
was 5 to 6 years. This age of clinical onset is consistent with an 
assumption that the average incubation period in the United Kingdom has 
been about 60 months. The average age of animals identified with 
disease in the EU is higher than this--the average was 86 months in 
2001 and has increased since then. This evidence indicates that 
considering certain tissues in bovines 30 months of age or older to be 
SRMs, and removing and disposing of those tissues, would eliminate the 
majority of infectivity present, and removing and disposing of these 
same tissues from bovines between 12 and 30 months of age would not 
provide any significant additional protection.
    This same point is illustrated in various models. Comer and Huntly 
(2003) modeled the potential human exposure available in the United 
Kingdom from 1980 through 2002. They concluded that an estimated total 
of 54 million bovine oral ID50 units could have been 
consumed in that timeframe. This period included both the beginning of 
the epidemic in cattle, before the disease was recognized and public 
health control measures were established, and later in the epidemic 
when control measures were developed and instituted. Comer and Huntly 
also concluded that 99.4 percent of this estimated exposure was from 
animals older than 30 months of age. Therefore, SRM restrictions from 
animals greater than 30 months would reduce the vast majority of 
potential exposure.
    In summary, we are in agreement with the conclusion that has been 
widely reached and that has generally been accepted internationally, 
that the primary public health protective measure regarding BSE is the 
removal of SRMs from the human food supply.
    Issue: One commenter stated that APHIS' assertion that the 
rendering process is important in the inactivation of the BSE agent is 
overstated.
    Response: As we stated in our January 2007 proposed rule, we 
recognize that standard rendering processes do not completely 
inactivate the BSE agent, and that rendered protein such as MBM derived 
from infected animals may remain contaminated. However, the rendering 
process is an important factor in BSE risk reduction for two reasons.
    First, standard rendering processes will inactivate significant 
levels of any BSE infectivity that might remain in materials sent to 
rendering by subjecting the material to intense heat and pressure. The 
risk assessment conducted for this rulemaking noted that the rendering 
process has proven to be effective in reducing the level of 
infectivity. This is based on data regarding inactivation by various 
rendering methods (Taylor et al., 1995; Taylor et al., 1997). The 
assumptions on this point used in the quantitative exposure model have 
been previously explained (Cohen et al., 2002, 2003) and include a 
range from 0 logs reduction in infectivity in a vacuum rendering

[[Page 53338]]

system to 3.1 logs reduction in a batch system. The proportions of 
cattle rendered in the various systems were also explained, with the 
majority of rendering (90 percent) done in either a continuous/fat-
added system (providing a 2.0 log or 99 percent reduction) or a 
continuous/no-fat-added system (providing a 1.0 log or a 90 percent 
reduction). On average, the rendering process inactivates 1.4 logs of 
infectivity, or greater than 97 percent.
    Additionally, rendering serves as a critical control point in 
redirecting ruminant proteins away from cattle feed. In the risk 
assessment we conducted for this rulemaking, we explained that the 
rendering process will contribute to the prevention of BSE as part of a 
series of sequential barriers, rather than as an independent barrier.
    Issue: One commenter expressed concerns about plate waste as a 
potential pathway for BSE infection of U.S. cattle, because the 
proposed rule did not prohibit the feeding of plate waste, including 
beef, to cattle. The commenter referred to APHIS' risk analysis that 
accompanied the rulemaking related to the importation of boneless beef 
from Japan (70 FR 73905-73919, Docket No. 05-004-2), which concluded 
that the plate-waste pathway did not present a significant BSE risk, 
and stated that the conclusion reached in that risk assessment would 
not be applicable regarding beef from Canada, because the expected 
amount of product from Canada would be much greater than that projected 
for importation from Japan.
    Response: We do not agree with the commenter that plate waste is a 
potentially significant BSE pathway due to this rule. In the risk 
analysis we conducted for the rule related to the importation of 
boneless beef from Japan, we discussed direct and indirect exposure 
pathways by which such beef might expose U.S. cattle to BSE if the 
product contained the BSE agent. In addition, we stated in unequivocal 
terms that the primary factors limiting the likelihood that whole cuts 
of boneless beef imported from Japan would expose the U.S. cattle 
population to BSE are (1) the inherently low risk of the product, (2) 
measures to prevent contamination, which would be the same for any beef 
from cattle from Canada that might become plate waste, and (3) the fact 
that the product is unlikely to be fed to cattle.
    Although we recognized in our rulemaking for boneless beef from 
Japan that the product (inherently low-risk boneless beef) is not 
intended for animal consumption, we evaluated pathways by which some 
small fraction of the product might inadvertently be fed to cattle. We 
considered the possible pathways to include restaurant trimmings and 
plate waste, and the direct feeding of human food waste to cattle. We 
further evaluated pathways by which home food waste and plate waste can 
be fed directly to cattle, and we did not identify any 
epidemiologically significant pathways for exposure of the U.S. cattle 
population. Specifically for plate waste, which is allowed to be 
incorporated into ruminant feed, we considered that the amount of meat 
in the plate waste would be insignificant (Cohen et al., 2001; 2003). 
Furthermore, because FDA requires that the plate waste be further heat 
processed for feed, it may be subject to rendering processes that will 
inactivate significant levels of the agent, further reducing the level 
of infectivity in the rendered product. (Cohen et al., 2001; 2003).
    The inherent (low risk) characteristic of the product imported 
under the Japan rule, coupled with the measures to prevent 
contamination of the product and the fact that the product is unlikely 
to be fed to cattle, were the primary factors in our evaluation. We did 
not dismiss any risk based on quantity. We considered the level of 
imports specifically under that rule as an additional limiting factor 
for any infectious material, if present, in the product.
    Canadian cattle imported under this final rule will be slaughtered 
for edible meat production at slaughter plants within the United States 
and would be subject to FSIS' slaughter restrictions. These 
restrictions include ante-mortem inspection and prohibition of the 
slaughter of downer animals. In addition, FSIS requires the removal of 
SRMs, which is a critical risk measure preventing contamination of 
edible meat with BSE infectivity. We consider these measures, combined 
with the fact the edible meat is inherently low risk for the BSE agent, 
to be sufficient to mitigate the risk of exposing U.S. cattle to the 
BSE agent, if present, via plate waste.
    Issue: One commenter noted that a peer reviewer of the 2005 Harvard 
Risk Assessment of Bovine Spongiform Encephalopathy Update: Phase IA 
suggested lowering the estimate that, at ante-mortem inspection, a 
Federal inspector will identify BSE symptoms in infected animals 90 
percent of the time. The commenter stated further that the Canadian BSE 
cases have not been clinical suspects.
    Response: The FSIS revision of the ante-mortem assumptions 
demonstrates that the assumed ante-mortem detection rate does not 
strongly influence the results of the analysis. The commenter noted 
that cutting the detection rates to 50 percent (ambulatory animals) and 
25 percent (non-ambulatory animals) increases the projected number of 
infected animals by approximately 5 percent. Importantly from the 
perspective of APHIS, this revision had a limited impact on 
R0. The revised FSIS assessment (dated December 26, 2006) 
included several changes relative to the original FSIS assessment 
(dated October 31, 2005).\9\ The mean value of R0 increased 
from 0.24 in the original FSIS assessment to a mean value of 0.27 in 
the revised FSIS assessment. The 95th percentile estimate for R0 
increased from 0.45 in the original FSIS analysis to 0.48 in the 
revised FSIS analysis. In conclusion, the FSIS analysis indicates that 
changing the ante-mortem assumptions does not appreciably alter the 
projected spread of BSE. On the basis of the FSIS finding, APHIS 
concludes that a change in the ante-mortem detection rate of this 
magnitude does not qualitatively alter APHIS' conclusions, and 
therefore does not merit revision to the simulation model.
---------------------------------------------------------------------------

    \9\ The original and the revised FSIS assessments may be viewed 
at http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp.
---------------------------------------------------------------------------

    Issue: One commenter cited published literature described in the 
risk assessment to point out the levels (in grams) of highly infective 
brain tissue that resulted in infection of calves following 
experimental oral exposure. The commenter then asked if, after gauging 
what dosage is necessary to transmit BSE orally, the risk to each 
animal should be calculated based on the number of times it has a 
feeding.
    Response: There is no need to revise the model in response to this 
comment for the following reasons. First, the model does not assume any 
threshold below which exposure to BSE would pose zero risk of 
infection. Second, and as a result of the first point, the model 
assumes that every exposure event incrementally contributes to the risk 
of infection.
    Issue: One commenter noted that the number of infected animals that 
survive sufficiently long enough to develop clinical disease is always 
small in the exposure assessment (even under very pessimistic 
assumptions), and that, presumably, clinical animals will come 
primarily from those animals characterized as ``beef repro'' and 
``dairy'' (APHIS 2006b, table 5). The commenter questioned whether the 
estimates of animals imported in these classes of animals and their 
time-

[[Page 53339]]

dependent removal (death, slaughter, and cull) rates from the 
population before clinical signs develop were realistic and validated.
    Response: This comment appears to consist of two parts. In the 
first, the commenter asks if the estimates of numbers of imported 
breeding animals are realistic and valid, and in the second, the 
commenter asks if the time-dependent removal of these animals is 
realistic and valid. Because different sources of evidence support 
these two components of the question, we address them individually in 
the following discussion.
    As we explained in response to another comment, our estimates of 
imports of all cattle classes, including breeding animals, were 
developed by USDA, ERS. They are based on a well-accepted, iterative 
method involving expert opinion and country-commodity specific 
modeling. Based on the above description of this process, we expect 
that alternative plausible assumptions for the number of imported 
breeding animals would not likely vary substantially from those based 
on the most current inputs.
    With regard to the commenter's questions about time-dependent 
removal of these animals (i.e., at what point animals are removed from 
the cattle population by, e.g., slaughter) APHIS notes that imported 
animals are integrated into the U.S. herd and thus are removed 
(slaughtered) using the same distribution used for native-born U.S. 
cattle. The slaughter parameter used in the Harvard model (Cohen et 
al., 2003) ``represents the probability that cattle will be sent to 
slaughter. This probability depends on the [animal's] type of 
production, age, and gender (e.g., steers and heifers are sent to 
slaughter earlier than dairy cows or reproductive beef animals).'' The 
developers of the model based the associated assumptions for the 
parameter on the following sources, listed in Cohen et al. 2003: USDA 
(U.S. Department of Agriculture 1998a), Radostits et al., 1994, and 
several personal communications (Clay 2001; Crandall 2001; Pinter 
2001). The model and its parameters have been subject to previous peer 
review and have been found to be realistic.
    Issue: One commenter expressed concern that, if an undetected BSE-
infected cow were imported into a family herd and, upon becoming 
incapacitated, were sent to a local small rural facility to be 
processed into beef for the cow's owners, BSE could enter the food 
chain.
    Response: The commenter seems to be concerned about the possibility 
of BSE entering the human food chain after a cow is slaughtered for 
personal use at a custom slaughter facility. However, such usage would 
be in contravention of FSIS regulations. FSIS prohibitions on the use 
of SRMs for human food apply to cattle slaughtered for personal use at 
custom facilities, as does FSIS' prohibition of the use of all non-
ambulatory disabled cattle in the human food chain (FSIS 2007).
    Issue: A number of commenters recommended that the provisions of 
the proposed rule not be implemented unless focused testing for BSE of 
cattle imported from a BSE minimal-risk region is carried out at 
slaughter. A number of commenters recommended that any bovine 30 months 
of age or older imported into the United States from a BSE minimal-risk 
region be tested for BSE before being used for food. Several commenters 
recommended that USDA require testing for BSE of all cattle imported to 
the United States from countries in which BSE has been diagnosed, such 
as Canada. One commenter recommended that the proposed rule not be 
implemented until rapid-test technology for BSE is provided to all U.S. 
slaughtering facilities. Another commenter recommended that USDA allow 
slaughter establishments to conduct additional tests to satisfy 
consumer demands.
    Response: Our peer-reviewed risk assessment concluded that the 
likelihood of BSE release from cattle imported from Canada is likely to 
be extremely low because (1) the prevalence of BSE in Canada is 
extremely low, and (2) measures requiring imported animals to be born 
on or after March 1, 1999, will further decrease the likelihood that 
those animals had been exposed to infectious material. Moreover, the 
exposure assessment for live animals qualitatively indicates that 
because of the barriers to BSE transmission in the United States, the 
likelihood of BSE exposure and establishment in the U.S. cattle 
population as a consequence of infectivity introduced via imports from 
Canada is negligible.
    Further, although we understand the interest expressed by some 
commenters in testing certain cattle for slaughter, such comprehensive 
testing would not necessarily yield accurate or useful results. Current 
testing methodology can detect a positive case of BSE only a few months 
before the animal begins to demonstrate clinical signs. The incubation 
period for BSE--the time between initial infection and the 
manifestation of clinical signs--is generally very long--on average 
about 5 years, which means that there is a long period during which 
testing an infected animal would produce negative but incorrect 
results, especially if the animal is clinically normal. The import 
projections anticipate that the majority of animals imported for 
immediate slaughter and/or for feeding and subsequent slaughter are 
young animals, generally slaughtered at less than 30 months of age. 
Since current tests only determine the presence of BSE shortly before 
the likely onset of symptoms, testing young, apparently normal animals 
is not an effective use of the tests. In addition, since SRM removal 
requirements are in place, testing apparently normal animals at 
slaughter does not provide any significant additional public health 
protective measure. Heim and Kihm (2003) note that it is questionable 
whether testing all animals at slaughter provides any measurable 
increase in consumer safety. Additionally, they note that such testing 
can be counter-productive since measures such as SRM removal may not be 
sufficiently emphasized due to the perceived total reliability of the 
testing. Given that testing of clinically normal, apparently healthy 
cattle does not provide meaningful data, combined with the conclusions 
of the risk assessment concerning the extremely low likelihood of 
release and negligible likelihood of exposure and establishment in the 
U.S. cattle population, testing these animals at slaughter as 
commenters suggest is not appropriate at this time.
    Issue: A number of commenters stated that APHIS should not expand 
the types of bovines allowed importation from a BSE minimal-risk region 
until it can be shown that the current U.S. regulations are being 
adequately enforced. Several commenters cited as an example of 
inadequate enforcement an incident involving the importation and 
movement to slaughter in the United States of Canadian cattle over 30 
months of age. Of those commenters, some expressed concern regarding 
the time it took to trace the animals back.
    Several commenters stated that records from Washington State 
suggest that Washington and several other States are having difficulty 
tracking hundreds of cattle that arrive from Canada each week. Other 
commenters stated that a number of cows entered the United States from 
Canada without ear tag identification or certificates of health, or had 
eartag identification that did not match the accompanying health 
certificate.
    Response: The commenters referenced an alleged violation of the 
regulations in which imported Canadian feeder cattle

[[Page 53340]]

were reportedly sold through an auction market in the United States. A 
detailed investigation into the incident demonstrated that the animals 
in question were legally imported for immediate slaughter.
    Commenters also referenced issues that State authorities identified 
in tracking imported animals. Certain States instituted policies or 
regulations that required additional movement controls and verification 
beyond the APHIS import requirements. In these instances, it is the 
responsibility of the State authorities to monitor compliance with 
their regulations and to follow up on any reported violations. APHIS 
can assist in resolving issues if requested.
    APHIS port veterinarians inspect all live animal shipments entering 
the United States. These inspections include careful review of the 
health certificate accompanying the animals and a visual inspection of 
the animals. Live cattle presented at the port of entry with no 
accompanying valid health certificate are denied entry. We are not 
aware of any instances where shipments of cattle have entered through a 
designated port of entry without a health certificate. We recognize 
that animals can lose eartags at various points in the process and have 
established procedures to reapply eartags with appropriate 
documentation. In addition, apparent transposition of digits or similar 
errors in recording eartag numbers can often be addressed during 
consultation with CFIA and/or the private veterinarian involved.
    APHIS is not aware of significant or repeated violations of the 
existing APHIS import regulations, and no evidence of such violations 
has been provided by the commenters concerned. Individual instances of 
errors or violations can, and have, occurred. These are investigated 
and dealt with appropriately. At no time have any of these errors 
presented a significant threat to animal or public health.
    Issue: One commenter stated that the animal health risk assessment 
does not address the risks to the U.S. cattle industry, or to human 
health, of having additional BSE cases discovered in the United States.
    Response: We disagree with the commenter. In our risk assessment, 
we addressed both the likelihood and the consequences of the adverse 
event of concern. We examined the likelihood of BSE becoming 
established in the United States, as well as the incremental 
consequences that may occur for every additional case that might be 
detected as a result of implementing the proposed rule. As discussed in 
the consequences section of the risk assessment, based on the responses 
to cases discovered in the United States since the initial finding of 
BSE in Canada in 2003, we do not expect additional costs (such as 
further closure of export markets or reduction in domestic 
consumption). When combined with the expected number of clinical cases, 
the resulting risk estimation is negligible, as discussed in the risk 
estimation section of the risk assessment. Determining what portion of 
the finding of negligible risk might be borne by the U.S. cattle 
industry, as the commenter requests, is unnecessary for the purposes of 
our risk assessment. Because we have determined the overall risk to be 
negligible, we do not consider it warranted to subdivide what is 
already a negligible risk in assessing its potential impact on various 
sectors.
    The overall economic consequences of the proposed rule on trade 
were addressed by the Preliminary Regulatory Impact Analysis that was 
conducted for the proposed rule. That document concluded that, although 
larger net welfare benefits may be realized under the scenario of no 
restriction by date of birth on live bovine imports, the proposed rule 
is preferable because it would pose a lower risk of BSE infectivity 
entering the United States via imports of live bovines from Canada. In 
response to public comments, the revision of this analysis published 
with the final rule has further examined the welfare effects on certain 
sub-categories of the cattle industry.
    As noted, the risk assessment specifically examines animal health, 
not human health. However, there would be no impact of detected cases 
on human health, because such animals would be removed from the human 
food supply. The risk assessment did, however, note the following and 
indicated that additional discussion of the human health aspects were 
included in the environmental assessment. ``Thus, although human health 
is not the focus of this assessment, we note that, even our 
quantitative model, which includes multiple sources of risk over-
estimation, indicates that, over the 20 years of the analysis, only 45 
cattle oral infectious dose-50 (ID50) units will be 
available for human exposure.'' In comparison, as discussed above, 
Comer and Huntly (2003) estimated that 54 million bovine oral 
ID50 units were available for human consumption in Great 
Britain from 1980 to 2003. This extremely large amount of available 
infectivity has resulted in 165 cases of vCJD identified in the United 
Kingdom through April 2007, plus a few additional cases identified in 
other countries but attributed to exposure in the United Kingdom. When 
compared to the United Kingdom's BSE experience and the associated 
estimate of available bovine oral ID50 units, the expected, 
or average value of 45 cattle oral ID50 would result in a 
miniscule amount of the BSE infective agent that could possibly be 
available for potential human exposure in the United States over a 20-
year period (APHIS 2006). The potential for human exposure under this 
scenario is estimated at 1,200,000 times less in the United States than 
what the United Kingdom experienced during its BSE epidemic. Whereas 
potential human exposure to infectivity is expected to be miniscule and 
epidemiologically insignificant, exposure (and hence potential human 
health impacts) due to detected cases would be nonexistent; detected 
cases of BSE are removed from the food supply.

OIE Guidelines

    The OIE is recognized by the World Trade Organization (WTO) as the 
international organization responsible for development and periodic 
review of standards, guidelines, and recommendations with respect to 
animal health and zoonoses (diseases that are transmissible from 
animals to humans). The OIE guidelines provide a science-based 
reference document for international trade in animals and animal 
products. The OIE guidelines for trade in terrestrial animals (mammals, 
birds, and bees) are detailed in the Terrestrial Animal Health Code 
(OIE, 2006a). The OIE guidelines on BSE are contained in Chapter 2.3.13 
of the Terrestrial Animal Health Code and are supplemented by Appendix 
3.8.4 of the Code.
    Some commenters stated that our proposed rule was inconsistent with 
OIE guidelines. We discuss below those areas addressed by the 
commenters.
    Issue: Several commenters stated that the proposed rule is 
inconsistent with OIE guidelines because it did not require'as the 
commenters stated OIE guidelines recommend--that for countries that do 
not have an effectively enforced feed ban that is reducing the 
incidence of BSE, the vertebrae and all other SRMs be removed from 
cattle over 12 months of age.
    Response: The OIE-recommended guidelines regarding BSE contain 
criteria for categorizing the risk of a country as either negligible 
risk, controlled risk, or undetermined risk. The basis for 
categorization encompasses several factors, including a risk 
assessment, surveillance efforts, regulatory structure for notifiable 
diseases, and education and awareness efforts. Canada has an 
effectively enforced feed ban. Further, Canada has been categorized by 
the OIE as

[[Page 53341]]

controlled risk (OIE 2007b), rather than as undetermined risk as 
implied by the commenters. The OIE guidelines recommend that certain 
SRMs be removed from cattle over 30 months of age for exports from 
countries that are considered controlled risk, and cattle over 12 
months of age for exports from countries that are considered 
undetermined risk.
    Issue: Several commenters stated that the proposed rule did not 
comply with OIE guidelines for either controlled risk or undetermined 
risk countries regarding the birth date of cattle in relation to the 
date of effective enforcement of a feed ban. The commenters stated that 
the OIE recommends that cattle not be exported from a country of 
undetermined risk for BSE, which the commenters stated Canada qualifies 
as, unless the cattle were born at least 2 years after the feed ban was 
effectively enforced. Nor, said the commenters, did the proposed rule 
meet the OIE guidelines that cattle not be exported from a controlled 
risk country until after the date a feed ban was effectively enforced.
    Response: We disagree with the commenters. As noted previously, the 
OIE has categorized Canada as controlled risk. Our proposed changes are 
consistent with the OIE guidelines for trade in live animals from a 
controlled risk region. As part of the risk analysis that APHIS 
conducted in conjunction with its January 2005 final rule that 
recognized Canada as a BSE minimal-risk region, APHIS evaluated a 
series of measures introduced in Canada to prevent the feeding of 
ruminant proteins to ruminant animals. USDA considered the compliance 
activities reported by CFIA as well as epidemiological information in 
concluding that compliance with the feed ban was good, and that the 
feed ban was effectively enforced.
    The OIE guidelines do not define how to determine the date the feed 
ban was effectively enforced. APHIS identified March 1, 1999, as the 
date of effective enforcement of the feed ban in Canada based on a 
careful evaluation of the full panoply of features employed by the feed 
ban and consideration of regulatory enforcement actions (i.e., a 
practical implementation period) and sufficient additional time to 
allow previously manufactured feed to cycle through the system.
    Issue: Several commenters stated that APHIS published the proposed 
rule despite the fact that Canada does not meet OIE guidelines for 
testing for BSE, and requested that APHIS withdraw or delay this 
rulemaking until Canada significantly increases its BSE testing. One 
commenter stated that, to meet OIE testing guidelines, Canada needs to 
test with negative results 187,000 consecutively targeted cattle with a 
BSE risk equal to that in the casualty slaughter age between 4 and 7 
years, in order to be confident that the BSE prevalence in Canada is 
not more than 1 in 100,000. However, said the commenter, Canada tested 
only 143,528 total cattle in the period from 2004 through February 12, 
2007, with 8 positive cases found during that period.
    Response: We disagree with the conclusions and assertions of the 
commenters. The OIE Terrestrial Animal Health Code, 2006, Appendix 
3.8.4, contains guidelines for BSE surveillance. These guidelines 
describe a weighted points system for BSE surveillance samples and 
suggest total points targets for what is considered as either Type A or 
Type B surveillance. As noted in the Code, ``The application of Type A 
surveillance will allow the detection of BSE around a design prevalence 
of at least one case per 100,000 in the adult cattle population in the 
country, zone or compartment of concern, at a confidence level of 95 
percent.'' Based on this definition, we assume the comments described 
above refer to Type A surveillance. The points target for Type A 
surveillance in a country such as Canada with an adult cattle 
population of more than 1,000,000 is 300,000 points, to be obtained 
over a 7-year period.
    Under the OIE guidelines, specific ``point values'' are assigned to 
each sample, based on the surveillance stream or subpopulation of 
animals from which it was collected, as well as the likelihood of 
detecting infected cattle in that subpopulation. Table 4, below, 
outlines the point values for samples obtained from the different 
surveillance streams:

    Surveillance Point Values for Samples Collected From Animals in the Given Subpopulation and Age Category
----------------------------------------------------------------------------------------------------------------
                                           Surveillance subpopulation
-----------------------------------------------------------------------------------------------------------------
     Routine slaughter               Fallen stock             Casualty slaughter           Clinical suspect
----------------------------------------------------------------------------------------------------------------
                                            Age >1 year and <2 years
----------------------------------------------------------------------------------------------------------------
                  0.01                          0.2                         0.4                         N/A
----------------------------------------------------------------------------------------------------------------
                                     Age >2 years and <4 years (young adult)
----------------------------------------------------------------------------------------------------------------
                   0.1                          0.2                         0.4                         260
----------------------------------------------------------------------------------------------------------------
                                    Age >4 years and <7 years (middle adult)
----------------------------------------------------------------------------------------------------------------
                   0.2                          0.9                         1.6                         750
----------------------------------------------------------------------------------------------------------------
                                     Age >7 years and <9 years (older adult)
----------------------------------------------------------------------------------------------------------------
                   0.1                          0.4                         0.7                         220
----------------------------------------------------------------------------------------------------------------
                                               Age >9 years (aged)
----------------------------------------------------------------------------------------------------------------
                   0.0                          0.1                         0.2                          45
----------------------------------------------------------------------------------------------------------------

    As demonstrated in table 4, a sample from the specific surveillance 
subpopulation where BSE is most likely to be detected--i.e., a middle 
adult clinical suspect--provides the most surveillance points. 
Conversely, a sample from the subpopulation where BSE is least likely 
to be detected--

[[Page 53342]]

generally routine slaughter--provides the least points.
    It appears that the commenter calculated the number of samples 
necessary from an assumed surveillance subpopulation. That is, if a 
country samples only middle adult casualty slaughter animals at 1.6 
points per sample, it would need to sample 187,000 cattle in this 
specific subpopulation to obtain 300,000 points.
    However, it is inaccurate to compare such a calculation to Canada's 
surveillance efforts. The commenter referred to surveillance conducted 
in Canada from 2004 through February 2007--a period of slightly more 
than 3 years. However, as noted, the OIE guidelines provide for points 
targets to be met over a 7-year period. Therefore, a valid comparison 
of the OIE guidelines and the testing conducted in Canada would need to 
be based on surveillance totals from, e.g., January 2000 through 
December 2006.
    More significantly, the commenter appeared to assume that Canada is 
sampling only one specific surveillance stream--casualty slaughter 
animals from 4 to 7 years of age. Attachment 1 of the risk assessment 
conducted for this rulemaking--``Estimation of BSE Prevalence in Canada 
(APHIS 2006c)''--contains tables that allocate Canadian surveillance 
samples into the different surveillance streams. In every year from 
1999 through August 2006, animals from three different surveillance 
streams--fallen stock, casualty slaughter, and clinical suspect--of all 
ages were sampled. Therefore, the points value for each sample will 
vary in line with the previously provided table. A summary of OIE 
points can be calculated from the information provided. For example, 
data from surveillance conducted in Canada in 2005 for only one 
surveillance stream--clinical suspect--show that, in that year, 2 
clinical suspects less than 2 years old were sampled (0 points), 43 
clinical suspects 2 to 3 years of age were sampled (11,180 points), 120 
clinical suspects 4 to 6 years of age were sampled (90,000 points), 68 
clinical suspects 7 to 8 years of age were sampled (14,960 points), and 
194 clinical suspects greater than 9 years of age were sampled (8,730 
points). Testing of the 194 clinical suspects sampled in 2005 provided 
a total of 124,870 points for this 1 surveillance stream in 1 year. The 
total number of OIE points accumulated by Canadian surveillance over 
the 7-year period ending at August 2006 is 922,176. This far exceeds 
the OIE point target of 300,000 points for Type A surveillance.
    Issue: Several commenters stated that the proposed rule did not 
comply with the OIE guidelines with regard to the importation of SRMs. 
The commenters stated that the OIE recommends that SRMs not be imported 
for feed or fertilizer and the proposed rule would allow SRMs to be 
used for non-ruminant feed and fertilizer.
    Response: The commenters are correct that the OIE guidelines 
recommend that certain tissues--SRMs--should not be traded. 
Specifically, the guidelines recommend that SRMs ``should not be traded 
for the preparation of food, feed, fertilizers, cosmetics, 
pharmaceuticals including biologicals, or medical devices.'' It also 
states that ``protein products, food, feed, fertilizers, cosmetics, 
pharmaceuticals or medical devices prepared using these commodities 
(unless covered by other Articles in this Chapter) should also not be 
traded.'' However, the Code also includes guidelines for trade in live 
cattle--from which such materials could be derived after export to the 
recipient country--from countries of any risk status, thus creating an 
apparent contradiction in recommendations.
    We recognized in our risk assessment that SRMs from live cattle 
imported under these conditions could enter the U.S. system, similar to 
SRMs from U.S. cattle. The assessment acknowledges that SRMs from 
imported animals--just as those from domestic animals--can enter the 
rendering system in the United States, and the quantitative exposure 
model in the risk assessment specifically simulates this situation.
    Certain rendered protein products--bone meal, for example--can be 
included in fertilizer. However, this is not a common practice in the 
United States, as the vast majority of rendered protein products are 
sold for use in animal feed. Raw or untreated tissues are not generally 
used as fertilizer, and in fact are often prohibited from being spread 
on land. Therefore, any consideration of risk from fertilizer would be 
an evaluation of the risk of cattle exposure to oral consumption of 
fertilizer that contains in part rendered protein.
    Our quantitative exposure model evaluates the potential oral 
exposure of cattle to feed containing infected rendered protein 
products. It does not specifically model potential exposure through 
fertilizer. However, it assumes that all rendered ruminant protein 
products are sold for feed use. Therefore, any of the infectivity 
contained in rendered ruminant protein is simulated through the 
potential for direct feed exposure--either through misfeeding, cross-
contamination, or poultry litter. Feed constitutes a more significant 
pathway than potential consumption of a component of a fertilizer 
product after it is spread on a pasture. Therefore, any potential 
exposure through fertilizer would be assumed to be far less than 
exposure through feed, which is modeled in the risk assessment.
    For the reasons discussed above, we disagree that this rule is 
inconsistent with OIE guidelines. In those cases where one might see in 
the OIE guidelines an internal contradiction, that contradiction is 
much more apparent then real, and we consider this rule to be 
consistent with the intent and objectives of the guidelines. Therefore, 
we are making no changes based on the comments.

International BSE Classification of Canada and the United States

    Issue: At the time APHIS was accepting public comments on its 
January 2007 proposed rule, the OIE was in the process of completing 
its evaluation of countries internationally to determine which BSE risk 
category would be appropriate to each country evaluated. Several 
commenters recommended that our proposed rule be delayed until the OIE 
released its determinations. Commenters stated that waiting for release 
of the OIE designations would allow the U.S. categorization of BSE 
minimal-risk regions to be made consistent with OIE guidelines. 
Additionally, stated some commenters, the proposed rule could 
negatively influence the OIE's BSE risk categorization of the United 
States. One commenter recommended that the rulemaking be postponed 
until the European Food Safety Authority (EFSA) announced its BSE risk 
categorization of various countries, including Canada.
    Response: Under the OIE risk classification system, a country can 
be considered to be ``negligible risk,'' ``controlled risk,'' or 
``undetermined risk'' with regard to BSE. Based on the risk 
classification of a country, the OIE provides guidelines for the safe 
trade of cattle and cattle products. As noted above, at the May 2007 
annual General Session of the OIE International Committee, a list of 
countries recognized as being BSE controlled risk or negligible risk 
was confirmed. Both the United States and Canada were confirmed as BSE 
controlled risk countries (OIE 2007b).

Request To Allow Imports From the European Union

    Issue: One commenter requested that APHIS implement OIE import 
guidelines regarding BSE or,

[[Page 53343]]

alternatively, recognize the European Union as a BSE minimal-risk 
region.
    Response: As noted above, it is APHIS' intent to develop rulemaking 
that would incorporate OIE guidelines.

Commodities Eligible for Importation Under This Rule

    We proposed to allow the importation, under certain conditions, of 
live bovines for any use born on or after a date determined by APHIS to 
be the date of effective enforcement of a ruminant-to-ruminant feed ban 
in the region of export; blood and blood products derived from bovines; 
and casings and part of the small intestine derived from bovines.
    Although commenters addressed the provisions of our proposed rule 
regarding each of these commodities, the great majority of commenters 
focused on the potential importation of live bovines. We discuss below 
first the issues raised concerning live bovines, then the commenter 
issues regarding bovine blood and blood products and then those 
regarding the small intestine, including casings derived from the small 
intestine.
    Those commenters who addressed the importation of live bovines 
discussed which bovines should be eligible for importation with regard 
to usage and date of birth, identification of the animals, verification 
that the animals are imported in compliance with the regulations, 
sealing of means of conveyance carrying the animals, and monitoring of 
imported cattle once in the United States.

Live Bovines

Date of Birth Eligibility

    Issue: A number of commenters questioned how it will be determined 
whether a bovine intended for importation from Canada was born on or 
after March 1, 1999. The commenters stated that it will not be feasible 
to use dentition to determine the age of imported bovines, particularly 
in animals over 4 years of age. In many cases, said the commenters, 
Canadian veterinarians would have to accept producers' statements as 
the only source of verification of the age of the cattle. The 
commenters stated that the Canadian national cattle identification 
program was not made mandatory until 2002, and that it is still not 
mandatory in Canada to enter the entire birth date information into the 
database. Several commenters stated that it is nearly impossible to 
verify the actual age of older Canadian cattle, because the Canadian 
animal identification requirement applies only to cattle that leave the 
farm.
    Response: The provisions in Sec.  93.436(a)(3) and (b)(4) of this 
rule provide that bovines are not eligible for importation from a BSE 
minimal-risk region unless they are accompanied by certification that, 
among other things, the animals were born on or after March 1, 1999. As 
provided in Sec.  93.405(a), such certification must be issued by a 
full-time salaried veterinary officer of the national government of the 
region of origin, or by a veterinarian designated by the national 
government of the region of origin and endorsed by a full-time salaried 
veterinary officer of the national government of the region of origin, 
representing that the veterinarian issuing the certificate was 
authorized to do so. It is incumbent upon the individual issuing or 
endorsing the certificate to ascertain whether an animal's date of 
birth can be determined with the accuracy necessary for such 
certification. As the commenters imply, dentition can be used to 
adequately determine the birth date of animals below about 4 years of 
age. Specifically, if an animal does not have all of its permanent 
teeth erupted, it is less than 4-5 years of age and therefore was born 
after March 1, 1999. However, if all permanent teeth are present and in 
wear, dentition does not provide an estimate of birth date specific 
enough to support certification that the animal was born on or after 
March 1, 1999.
    We recognize that Canada's mandatory identification requirements 
did not take effect until 2002, and also that these requirements do not 
mandate that birth date information be entered into the database. 
However, we also note that provisions have been established for birth 
date information to be entered at any time, with appropriate 
documentation available to support such information. The number of 
these age-verification entries continues to increase, with over 3.5 
million birth dates submitted to the Canadian Cattle Identification 
Agency (CCIA) database by late 2006 (CCIA, 2006). We recognize that it 
is likely that owners of some bovines may not be able to provide the 
documentation regarding an animal's birth date that is necessary for 
the required certification. In those cases, even if an animal was born 
on or after March 1, 1999, the animal would not be eligible for 
importation into the United States.

Permanent Identification of Country of Origin

    Issue: Under the provisions of the proposed rule, cattle imported 
from Canada for other than immediate slaughter would have to be 
permanently and humanely identified before arrival at the port of entry 
with a distinct and legible mark identifying the exporting country. As 
proposed, acceptable means of permanent identification would include a 
mark applied with a freeze brand, hot iron, or other method; a tattoo 
applied to the inside of one ear of the animal, or other means of 
permanent identification if deemed adequate by the Administrator. For 
bovines imported from Canada, a brand would have to read ``C[Lambda]N'' 
and a tattoo would have to read ``CAN.''
    A number of commenters addressed the issue of permanent 
identification of bovines as to the country of export. Several 
commenters recommended that the regulations require that such 
identification be applied with a hot-iron brand, and that a ``hair 
brand'' not be considered acceptable means of identification.
    Response: A hair brand would not meet the requirements of the 
regulations, in that it could not be depended upon to provide permanent 
identification of the animal's country of export. However, we do not 
consider it necessary to list in the regulations all the forms of 
identification that would not be considered adequate to meet the intent 
of the regulations.
    Issue: Several commenters addressed the requirement for permanent 
identification of the country of export as it would apply to bison. The 
commenters stated that a brand on the right hip or an ear tattoo are 
not the preferred alternatives, because of unnecessary stress on the 
animals and handlers. The commenters stated that a more humane means of 
bison identification, such as electronic tags (dual tags if necessary), 
could readily meet the need of tracking the origin of the bison and the 
movement patterns in Canada and the United States.
    Response: The type of identification recommended by the commenters 
would provide the individual unique identification required by the 
regulations to facilitate traceback of the animal. Although the current 
regulations in Sec.  93.436 require that such identification be 
provided by an official eartag of the country of origin, in August 2006 
we have proposed to allow for forms of individual identification other 
than eartags.\10\
---------------------------------------------------------------------------

    \10\ We proposed (71 FR 45439-45444, Docket No. APHIS-2006-0026) 
to allow the individual identification to be provided with some form 
of identification other than an eartag. We solicited comments 
concerning our proposal for 60 days ending October 10, 2006. On 
November 9, 2006, we published a document in the Federal Register 
(71 FR 65758-65759, Docket No. APHIS-2006-0026) reopening and 
extended the comment period until November 24, 2006. We received a 
total of 10 comments by that date. We are considering the issues 
raised by the commenters and will address them in a separate 
rulemaking document.

---------------------------------------------------------------------------

[[Page 53344]]

    However, we consider it necessary that the animal also be marked in 
some permanent and easily visible way as having been imported from a 
BSE minimal-risk region. In the case of bison from Canada, this would 
be a brand or other permanent ``C[Lambda]N'' mark on the right hip, an 
ear tattoo with the letters CAN, or some other means of permanent 
identification if deemed adequate by the Administrator to humanely 
identify the animal in a distinct and legible way as having been 
imported from the BSE minimal-risk exporting region. The type of 
identification recommended by the commenters would not allow for easily 
visible identification of the country of origin.
    Issue: A number of commenters disagreed that an ear tattoo would be 
an effective permanent means of identifying the country of origin of a 
bovine. The commenters stated that tattoos applied inside an animal's 
ear frequently become illegible after a period of time, and further, 
that tattoos may not be visible without catching the animal and 
examining it in a chute or other restraint system. The commenters 
recommended that, if tattoos are allowed, the regulations require that 
animals so identified be restrained and examined in the country of 
export to confirm that the tattoo is legible and permanent, and that 
such confirmation be indicated on signed documentation accompanying the 
animals to the United States.
    Response: As discussed in our proposed rule, we agree that tattoos 
might not be the most readily visible means of identification of live 
animals in groups of animals. However, the purpose of requiring 
permanent identification of the animal's country of export is to 
expedite initial identification of an animal's country of export in the 
event the animal is diagnosed with BSE. Such a diagnosis cannot be 
confirmed on a live animal. Once the animal has been euthanized or has 
otherwise died, an ear tattoo will be an effective means of 
identification.
    Issue: Several commenters stated that the APHIS Administrator 
should be required, upon request, to evaluate alternative means of 
permanent identification and, if they are functionally equivalent to 
the existing methods, be required to approve them.
    Response: Paragraph (b)(2)(iii) of Sec.  93.436 (of this rule 
provides for such approval by the Administrator of alternative means of 
permanent identification.
    Issue: Several commenters recommended that a hot-iron brand on the 
right hip be required on all cattle crossing the U.S. border.
    Response: As noted above, we proposed to require a permanent mark 
identifying the animal's country of origin only for cattle imported 
from a BSE minimal-risk region for other than immediate slaughter. We 
do not consider it necessary for cattle imported from a BSE minimal-
risk region for immediate slaughter to be permanently identified as to 
country of export. Such animals will be moved to the slaughtering 
establishment in a group and the movement documentation accompanying 
such animals will be sufficient to provide ready identification of the 
animals' country of origin.
    Issue: One commenter recommended that the regulations require that 
each animal entering the United States have permanent identification by 
which the animal could be traced back to its farm of origin.
    Response: The commenter's recommendation refers to two types of 
identification that are already addressed by this rule. In this rule, 
paragraphs (a)(2) and (b)(3) of Sec.  93.436 already require each 
bovine imported into the United States from a BSE minimal-risk region 
to be officially identified with an official eartag that provides 
unique individual identification that is traceable to the premises of 
origin of the animal. (As noted above, we have proposed to allow for 
forms of individual identification other than eartags). This rule 
requires, further, that no person may alter, deface, remove, or 
otherwise tamper with the official identification while the animal is 
in the United States or moving into or through the United States, 
except that the identification may be removed at the time of slaughter.
    In addition to the individual identification that allows for 
traceback to the animal's premises of origin, the regulations also 
require that all cattle imported from a BSE minimal-risk region be 
permanently identified as to country of origin as described above. As 
discussed above, we do not consider it necessary for bovines imported 
for immediate slaughter to have this additional permanent 
identification as to country of origin.
    Issue: One commenter requested that APHIS provide details of its 
protocol and criteria for ensuring that all live cattle imported from 
Canada have permanent identification maintainable until harvest.
    Response: In Sec.  93.436(b) of this rule, we give examples of 
means of permanent identification that would be considered acceptable. 
Acceptable types of permanent identification include a mark applied 
with a freeze brand, hot iron, or other method, or a tattoo applied to 
the inside of one ear of the animal. Any other types of permanent 
identification approved by the Administrator would have to be as 
effective as the examples cited in providing a permanent, distinct, and 
legible mark.

Individual Identification of Bovines

    Issue: One commenter recommended that all cattle imported from 
Canada that are not moved directly to slaughter be required to be 
identified by a low frequency ISO compliant radio frequency tag placed 
in the left ear.
    Response: As noted above, we have proposed to provide for forms of 
individual identification other than eartags, provided the 
identification can be used to trace the animal back to its premises of 
origin. We do not consider it necessary to mandate the use of any 
particular technology for meeting that criterion.
    Issue: One commenter recommended that the regulations require that 
animals intended for importation into the United States from a country 
with a verified case of BSE be enrolled in a third-party source and age 
identification program that uses individual electronic identification 
devices.
    Response: With regard to bovines intended for importation into the 
United States from a BSE minimal-risk region, the regulations already 
require that such animals be individually identified with unique 
identification that enables traceback to the premises of origin of the 
animal. Additionally, under this rule, bovines imported from Canada 
must be accompanied by certification issued or endorsed by the Canadian 
Government that the animals were born on or after March 1, 1999. After 
having evaluated the veterinary infrastructure of countries wishing to 
import animals and animal products into the United States, APHIS 
accepts official certification from those countries that commodities 
intended for export to the United States are in compliance with U.S. 
import regulations, just as U.S. trading partners rely on official U.S. 
certification that products exported from the United States meet the 
recipient country's requirements.

Sealing of Means of Conveyance

    Issue: The regulations for importing live bovines from BSE minimal-
risk regions have required that the bovines

[[Page 53345]]

be imported in a means of conveyance sealed in the region of origin 
with seals of the national government of the region of origin. In our 
proposed rule, we proposed to remove the requirement that bovines 
imported into the United States from BSE minimal-risk regions for other 
than immediate slaughter enter the country in sealed conveyances. We 
additionally proposed to remove the requirement that means of 
conveyance carrying bovines into the United States from minimal-risk 
regions for immediate slaughter be sealed in the region of export and 
to require instead that means of conveyance carrying bovines into the 
United States from Canada be sealed at the U.S. port of entry with 
seals of the U.S. Government.
    Several commenters specifically supported the proposed change to 
require sealing of means of conveyance at the port of entry, rather 
than in the country of export.
    One commenter stated that the proposed change to require sealing at 
the port of entry would allow APHIS less oversight of shipments and 
less opportunity to ensure that each animal in the shipment is 
accurately identified and of the appropriate age.
    Several commenters recommended that APHIS specify which country or 
agency will be responsible for sealing a means of conveyance at the 
port of entry.
    Response: We disagree that requiring sealing of means of conveyance 
at the port of entry will allow APHIS less oversight of shipments or 
cause decreased ability to ensure that the animals are being shipped in 
compliance with the regulations. The primary verification that the 
animals meet the requirements of the regulations will remain as it has 
been--i.e., certification by the country of export that the 
requirements of the regulations have been met.
    However, we believe it is necessary to continue to require sealing 
of means of conveyance transporting bovines from Canada to immediate 
slaughter as a mitigative measure against diseases other than BSE. 
Cattle imported from Canada for immediate slaughter are not subject to 
tuberculosis and brucellosis testing requirements that would otherwise 
be applied to animals imported into the United States. Therefore, we 
would continue to require that such cattle be moved directly to 
slaughter in a sealed means of conveyance. (APHIS had been requiring 
such sealing at the port of entry even before our November 2003 
proposal regarding BSE. However, the requirement for sealing was being 
done as APHIS policy, and was not specified in the regulations.)
    As the commenters noted, this rule will remove the requirement that 
the sealing of the means of conveyance be done in the region of export. 
That requirement was included in the January 2005 final rule in 
response to comments from members of the public who expressed concern 
that requiring sealing at the port of entry could be harmful to the 
welfare and quality of the animals, due to delays at the port of entry. 
Under the provisions of this proposed rule, however, we do not expect 
undue delays of shipments at the port of entry. When a means of 
conveyance carrying bovines for immediate slaughter arrives at the U.S. 
port of entry, APHIS inspectors would confirm that the animals are as 
described on the certificate that must accompany the animals being 
imported, but generally would not require that the animals be offloaded 
from the means of conveyance. Therefore, requiring that the sealing of 
the means of conveyance take place at the port of entry would not cause 
measurable delay of the shipment. Further, sealing at the port of entry 
rather than in the region of export will reduce the time the animals 
will need to be contained in a sealed means of conveyance and reduce 
the likelihood that a seal will need to be broken between the time it 
is applied and the arrival of the animals at a slaughtering 
establishment.
    We do not consider it necessary to specify which agency will seal 
means of conveyance at the port of entry with seals of the U.S. 
Government. In each case, the means of conveyance will be sealed by an 
APHIS employee.

Movement of Cattle for Other Than Immediate Slaughter

    Issue: Some commenters who opposed allowing the importation from 
Canada of bovines 30 months of age or older urged the continuation of 
the current restrictions on movement in the United States of cattle 
moved to a feedlot, as well as continuation of the current requirements 
regarding sealing of conveyances carrying such animals and the 
requirement that the animals be accompanied by an APHIS-issued movement 
permit.
    Response: The sealing and movement restrictions referred to by the 
commenters were included in our January 2005 final rule to ensure that 
live bovines from BSE minimal-risk regions were imported and 
slaughtered before the age of 30 months. At the time we published that 
final rule, we had not formally assessed the disease risk of allowing 
the importation of live bovines 30 months of age or older from BSE 
minimal-risk regions. Since that time, we have conducted an assessment 
of the risk of such importations, which we discussed in our January 
2007 proposed rule and made available with that proposed rule. Our risk 
assessment indicates that there is a negligible likelihood of U.S. 
cattle being exposed to BSE and of BSE becoming established in the U.S. 
cattle population as a consequence of this rule.
    Under this final rule, bovines from a BSE minimal-risk region will 
not have to be imported and slaughtered before they are 30 months of 
age. Therefore, it is not necessary to retain provisions in the 
regulations that were designed to help ensure that bovines imported 
from a BSE minimal-risk region are moved directly to a feedlot and then 
to slaughter as an easily identifiable group.

Request To Exempt Cattle for Immediate Slaughter From Birth Date 
Requirement

    We proposed to require that live bovines imported from BSE minimal-
risk regions have been born on or after the date recognized by APHIS as 
the date of effective implementation of a ruminant-to-ruminant feed ban 
in the region of export. We proposed to apply this requirement to all 
bovines imported from a BSE minimal-risk region, whether they are 
imported for immediate slaughter or for some other usage.
    Issue: A number of commenters stated that the eligibility of cattle 
to be imported for immediate slaughter should not be dependent on when 
the animals were born. The commenters stated that such animals do not 
present a BSE risk justifying such a condition, and that APHIS has not 
demonstrated such a risk. Several commenters stated that the risk 
assessment APHIS conducted for the proposed rule is based on the 
premise that slaughter cattle will be eligible for importation from 
Canada no matter what their date of birth.
    Additionally, commenters argued that requiring cattle moving 
directly to slaughter to have been born on or after March 1, 1999, 
would be inconsistent with the January 2005 final rule, which provided 
for the importation of beef derived from cattle of any age if 
requirements for the removal of SRMs are met. The commenters stated 
that allowing the importation of beef from cattle of any age while 
prohibiting the importation of cattle born before March 1, 1999, 
suggests that SRM removal can be accomplished more effectively in a 
foreign country than in the United States.

[[Page 53346]]

    Commenters stated further that scientific evidence overwhelmingly 
demonstrates that the safety of food products derived from cattle is 
not dependent on the age of the animal, but on whether SRMs have been 
removed and disposed of. The commenters stated that complete control of 
cattle imported from BSE minimal-risk regions can be assured by 
requiring movement under Government seal, as we proposed. As an 
additional safeguard, stated the commenters, USDA regulations require 
that if an animal showing clinical signs of BSE risk is tested for the 
disease at slaughter, the carcass and parts derived from the animal 
cannot enter the food supply unless the animal tests negative for BSE.
    Response: The commenters who recommended allowing the importation 
of cattle of any age from BSE minimal-risk regions, regardless of date 
of birth, raised several distinct issues in support of their 
recommendations. We agree with the commenters who stated that the 
removal and disposal of SRMs is the key factor in the food safety of 
products from bovines used for human consumption. However, the risk 
assessment conducted for the proposed rule specifically addressed the 
risk to animal health. The risk of transmission to U.S. cattle occurs 
when infectious tissues--most likely SRMs--inadvertently and/or in 
contradiction to U.S. feed regulations are rendered and included in 
ruminant feed and fed back to cattle. The risk of BSE-infected SRMs 
being present in the United States, while minimal, might be increased 
to some extent if cattle from BSE minimal-risk regions were allowed to 
be imported for immediate slaughter regardless of date of birth. The 
commenters are incorrect that our risk assessment did not take into 
account the date of birth of slaughter cattle. As described in the risk 
assessment, the requirement that animals for import be born after a 
certain date is one mitigation step that helps reduce the risk that 
infected animals will be imported, and therefore helps reduce the 
possibility that their SRMs will be incorporated into the ruminant feed 
chain in the United States.

Request for Restrictions on Use of Imported Cattle

    Issue: As discussed above, we proposed to allow the importation of 
bovines from BSE minimal-risk regions for any use, provided the animals 
were born on or after the date recognized by APHIS as the date of 
effective implementation of a ruminant-to-ruminant feed ban in the 
region of export. This provision allows bovines to be imported for 
immediate slaughter or for some other usage, such as breeding or 
feeding and then slaughter. It differs from the regulations, that have 
been in place, which have limited the importation of bovines from BSE 
minimal-risk regions according to both the age of the animal and the 
intended usage of the animal in the United States (only those animals 
moved to immediate slaughter, or to one feedlot and then directly to 
slaughter, have been eligible for importation).
    A number of commenters opposed the proposed removal of restrictions 
on how cattle imported from BSE minimal-risk regions may be used. 
Although most of these commenters did not object to the importation of 
cattle born on or after the date of effective implementation of a feed 
ban if the cattle were moved in a sealed means of conveyance directly 
to immediate slaughter, or to a single feedlot and then to slaughter, 
they expressed concern regarding the potential importation of cattle 
intended for breeding or as replacement animals in dairy herds.
    Some of the commenters stated that BSE-infected cattle imported 
from BSE minimal-risk regions for breeding or herd replacement may not 
show clinical symptoms of BSE infection for many years, allowing BSE to 
incubate in U.S. cattle herds, and that an outbreak of BSE in the 
United States due to such imported cattle would be devastating to the 
U.S. dairy industry.
    A commenter stated that, at the 95th percentile confidence for 
model simulations of Canadian BSE prevalence in the APHIS risk 
assessment, 180 new BSE cases occur over 20 years, and that 90 percent 
of these new cases would be expected to be in animals already infected 
with BSE when imported from Canada. Therefore, stated the commenter, 
almost all new cases of BSE expected in the United States will be from 
BSE-infected cattle imported from Canada and that any U.S.-born cases 
will be the result of importing breeding animals. Commenters stated 
further that, according to USDA, younger cattle are more susceptible to 
BSE and require less BSE-contaminated feed to become infected, and that 
since it is likely that younger cattle will be the ones imported for 
breeding or replacement purposes, the chance of introducing BSE into 
the United States from Canada is magnified.
    Commenters stated that, although a series of risk mitigations are 
in place, these are different when it comes to animals imported for 
breeding versus those going directly to slaughter.
    Response: The risk of BSE transmission to U.S. cattle occurs when 
infectious tissues--most likely SRMs--inadvertently and/or in 
contravention of U.S. feed regulations are rendered and included in 
ruminant feed and fed back to cattle. This risk is the same whether the 
animals were imported for immediate slaughter or were imported for 
breeding and are slaughtered later, and the series of risk mitigations 
or steps that prevent the transmission of BSE are the same, regardless 
of the purpose of the imported animal. While it is true that the level 
of infectivity in a BSE-infected bovine has been shown to increase as 
an animal ages, the amount of infectivity in, for example, a 7-year-old 
cow infected at 1 year of age would be the same at slaughter whether it 
was imported as a 1-year-old infected cow and used for breeding in the 
United States until it was 7 years old, or whether it was imported as a 
7-year-old cull cow for immediate slaughter.
    The U.S. feed ban prohibits the use of most mammalian protein in 
ruminant feed. The mammalian protein referenced could be derived from 
slaughterhouse offal--including SRMs--from animals imported for 
immediate slaughter, or from slaughterhouse offal derived from animals 
imported for breeding that have reached the end of their useful life in 
the United States. The protein could also be derived from the carcass 
of an animal imported for breeding that died other than by slaughter. 
The feed restrictions on the use of rendered protein derived from any 
of those scenarios would be exactly the same.
    The commenters are correct that BSE-infected cattle may not show 
clinical signs for many years, due to the long incubation period for 
this disease as explained in the risk assessment. However, as long as 
the animals were born on or after March 1, 1999, the likelihood of any 
individual animal having been exposed to and infected with BSE, and 
subsequently releasing BSE infectivity into the United States, is 
negligible. There is no expected difference in the likelihood of BSE 
infection in two animals born on or after March 1, 1999, and raised in 
Canada, one imported into the United States as a young animal for 
breeding purposes and slaughtered at the end of its productive period, 
and one used as a breeding animal in Canada, and exported for immediate 
slaughter in the United States at the end of its productive period. 
Furthermore, BSE is not a contagious disease and does not spread by 
casual animal contact. Therefore, while an individual animal in a herd 
may be infected, that does not mean that other animals in that herd are 
at risk of becoming infected via spread from that animal.

[[Page 53347]]

    Regarding the commenter's reference to our model simulation, we 
believe the commenter did not correctly interpret the results from the 
simulation. For sensitivity analysis 5 (pessimistic value for assumed 
BSE prevalence in Canada), the 95th percentile value for total infected 
cattle in the United States over a 20-year period amounts to 180 
animals. The 95th percentile value for endogenous BSE-infected cattle 
over that period is 75, suggesting that 180-75 = 105 BSE cases are 
imported over that period, not 160 animals, as suggested by the 
commenter.\11\
---------------------------------------------------------------------------

    \11\ Note that this estimate for the 95th percentile for 
imported cases (105) is approximate. The 95th percentile values for 
the total number of infected animals (180) and the number of 
endogenous cases (75) are estimated independently. In particular, 
all of the trials are first ranked according to the total number of 
endogenous cases, allowing identification of the 95th percentile 
value. The same is then done in order to identify the 95th 
percentile value for the total number of BSE cases. As a result, the 
95th percentile values may be selected from different simulation 
trials. Because the number of endogenous cases influences the number 
of total cases, these two quantities are (imperfectly) correlated, 
however. That is, simulation trials that project a large number of 
endogenous cases also project a large total number of BSE cases. 
Hence, the actual 95th percentile value for the total number of 
imported BSE cases is likely to be similar to 105.
---------------------------------------------------------------------------

    Also, although our quantitative exposure models project that new 
cases of BSE in the United States would be transmissions secondary to 
the importation of infected cattle from Canada, we note that the United 
States has identified two indigenous cases of BSE. Given this fact, one 
cannot categorically state that any such cases identified ``will be 
from BSE-infected cattle directly imported from Canada.''
    We explained in the risk assessment that there is an apparent age-
susceptibility in regard to BSE, specifically noting that 
susceptibility in cattle declines with age. However, we disagree with 
the commenter's conclusion that, based on this fact, importing younger 
animals--specifically breeding animals as they are generally imported 
at less than 2 years of age--presents a magnified risk. Susceptibility 
is not the same as likelihood of being infected. As an example, the 
commenter's conclusion means that any animal born within the past 2 
years would have a higher likelihood of being infected than an animal 
born 6 years ago. Given equal exposure a younger animal may be more 
susceptible to infection. However, as noted in the risk assessment, the 
overall prevalence in Canada is extremely low and BSE controls such as 
the feed ban are effectively enforced, so the chance that a given 
animal of any age had been exposed to an adequate amount of infectivity 
at a susceptible age i.e., the likelihood of being infected) is 
extremely small.

Monitoring of Imported Cattle

    Issue: A number of commenters expressed concern that the proposed 
rule did not explicitly provide for a system to monitor the movement in 
the United States of cattle imported from BSE minimal-risk regions, 
specifically Canada. Some commenters limited their discussion to cattle 
30 months of age or older. Commenters recommended that the regulations 
include an accounting procedure capable of monitoring the movement of 
imported animals from entry into the United States until slaughter, 
including changes in ownership of the animals.
    Response: The regulations currently include movement conditions for 
bovines from BSE minimal-risk regions imported for other than immediate 
slaughter. Such bovines must be imported in a sealed conveyance and be 
moved directly from the port of entry to a feedlot identified on APHIS 
Form VS 17-130 or other movement documentation required by the 
regulations. The APHIS Form VS 17-130 or other movement documentation 
must identify the physical location of the feedlot, the individual 
responsible for the movement of the animals, and the individual 
identification of each animal. The bovines must remain at the feedlot 
until transported from the feedlot in sealed conveyances to a 
recognized slaughtering establishment for slaughter. While being moved 
to slaughter, the bovines must be accompanied by APHIS Form VS 1-27 or 
other movement documentation deemed acceptable by the Administrator, 
which must identify the physical location of the recognized 
slaughtering establishment, the individual responsible for the movement 
of the animals, the individual identification of each animal.
    In our January 2007 proposed rule, however, we proposed to remove 
each of the above requirements from the regulations. The requirements 
described above were implemented solely to help ensure that cattle 
imported from BSE minimal-risk regions were slaughtered at less than 30 
months of age--i.e., to preclude any diversion of the bovines to other 
uses in the United States that would result in a slaughter at some age 
30 months or older.
    We did not attempt, for that rulemaking, to assess the BSE risk 
associated with the importation of live bovines 30 months of age or 
older from a BSE minimal-risk region. However, as discussed in our 
January 2007 proposed rule and in this final rule, for this rulemaking 
we did assess the BSE risk associated with the importation of such 
animals, and concluded that the resulting BSE risk from the importation 
from Canada of bovines born on or after March 1, 1999--whether or not 
the bovines are 30 months of age or older when imported and 
slaughtered--would be negligible. Therefore, in our January 2007 
proposed rule, we proposed to remove the requirement in Sec.  
93.436(a)(1) of the current regulations that live bovines imported from 
BSE minimal-risk regions be less than 30 months of age when ported into 
the United States and when slaughtered.
    With the removal of the less-than-30-month age restriction on the 
importation of bovines from BSE minimal-risk region, any cattle 
imported from Canada--once certification has been presented to APHIS 
that the animals were born on or after March 1, 1999--will be able to 
be moved and handled in the United States in the same way as U.S.-born 
cattle.
    Scientific evidence strongly indicates that BSE, unlike most 
transmissible diseases of cattle, is not transmitted from live animal 
to live animal. BSE is not a contagious disease and, therefore, is not 
spread through casual contact between animals. Scientists believe that 
the primary route of transmission requires that cattle ingest feed that 
has been contaminated with a sufficient amount of tissue from an 
infected animal. Therefore, even a BSE-infected bovine poses no BSE 
risk to other bovines unless those other bovines are fed BSE-
contaminated materials from the infected animal. This route of 
transmission can be prevented by excluding potentially contaminated 
materials from ruminant feed, as is required in the United States.
    If a bovine imported from a BSE minimal-risk region were diagnosed 
as being infected with the disease, from a biosecurity standpoint, it 
would not be necessary to know its record of movement while in the 
United States. However, we would proceed to trace the bovine back to 
its herd of origin, in order to identify birth cohorts of the animal. 
Traceback to the animal's premises of origin would be facilitated by 
the animal's unique individual identification, which is required under 
the current regulations and continues to be required by this rule, and 
which must be traceable to the premises of origin of the animal.
    Issue: Several commenters stated that imports of bovines under the 
proposed rule should not be allowed until a mandatory cattle and 
premises identification program is implemented

[[Page 53348]]

throughout the United States. At the minimum, stated one commenter, 
USDA should amend the National Animal Identification System policy to 
allow for and integrate with mandatory identification when required for 
animal health programs.
    Response: As discussed in the preceding response, one of the 
requirements for the importation of bovines from BSE minimal-risk 
regions is that each animal have unique individual identification that 
is not removed from the animal, except at slaughter. Such 
identification is in addition to any cattle or premises identification 
that might be carried out under the U.S. national animal identification 
system, and would facilitate tracing an imported bovine that is 
determined to be infected with BSE to its herd of origin.
    For the reasons discussed above, we are making no changes based on 
the comments regarding the monitoring and identification of cattle 
imported into the United States from a BSE minimal-risk region.

Feed Cohorts of BSE-Infected Animals

    Issue: Several commenters stated that the regulations should 
specifically prohibit the importation from BSE minimal-risk regions of 
feed cohorts of BSE-infected cattle.
    Response: We do not consider it necessary to add such a provision 
to the regulations and are making no changes based on the comments. Our 
definition of a BSE minimal-risk region in Sec.  94.0 of the 
regulations includes a requirement that such regions conduct an 
epidemiological investigation following detection of BSE sufficient to 
confirm the adequacy of measures to prevent the further introduction or 
spread of BSE, and continue to take such measures. We described such 
investigations in our January 2005 final rule, as well as in the 
proposed rule and the risk analysis for that rulemaking. This 
description noted that CFIA conducts comprehensive epidemiological 
investigations, and one component of these investigations is to trace 
feed cohorts of confirmed BSE-positive cattle, in accordance with OIE 
guidelines. As a result of these traces, feed cohorts that remain alive 
are euthanized and tested for BSE. Therefore, since such animals would 
be euthanized, there is no need to specifically prohibit their 
importation.

Maternal Transmission of BSE

    Issue: One commenter stated that APHIS' policy of destroying 
progeny of BSE-positive cows, in accordance with OIE guidelines, 
demonstrates that APHIS acknowledges there is some risk of maternal 
transmission of BSE. The commenter expressed the opinion that APHIS' 
conclusion expressed in the proposed rule that infectivity is unlikely 
to localize to the fetal blood is based on scant scientific evidence 
that remains equivocal. The commenter stated that APHIS does not 
prescribe any action to mitigate the additional risk pathway of the 
importation of pregnant cattle and fetuses from pregnant cattle.
    Response: We disagree with the commenter and are making no changes 
based on the comment. In the proposed rule, we pointed out that, based 
on scientific and epidemiological data, maternal transmission of BSE is 
unlikely to occur at any appreciable level. In fact, maternal 
transmission can be ruled out in the majority of the cases born after 
the 1996 ban in the United Kingdom of all animal protein from livestock 
feed (DEFRA 2007b). Additionally, modeling studies using data obtained 
from the United Kingdom epidemic show that even if maternal 
transmission occurred at very small levels, it could not sustain an 
epidemic.
    The commenter states that the OIE continues to recognize the risk 
of maternal transmission. However, we note that the 2006 OIE guidelines 
contain no specific recommendations regarding the destruction of 
offspring of infected animals as part of an epidemiological 
investigation. These recommendations were removed after recognition 
that the possibility of maternal transmission is very low. In addition, 
the 2006 guidelines with regard to trade from controlled risk regions 
for BSE contain no specific restrictions regarding progeny of positive 
animals. While the 2006 guidelines did contain a restriction for 
progeny of positive animals with regard to trade with undetermined risk 
regions (i.e., ``cattle selected for export * * * are not the progeny 
of BSE suspect or confirmed females''), this reference was removed in 
the 2007 OIE general session. Therefore, all restrictions on the trade 
in progeny of BSE-positive animals have been removed from the current 
OIE guidelines. APHIS believes the weight of the scientific information 
and scientific consensus reflected in the OIE international guidelines 
support the conclusion that maternal transmission of BSE is unlikely to 
occur at any appreciable level, and that specific regulatory measures 
are not necessary or warranted.

SRM Removal

    Issue: One commenter stated that USDA regulations should require 
the removal of all SRMs from cattle imported from Canada at 30 months 
of age or older.
    Response: FSIS regulations require the removal of all SRMs from 
cattle slaughtered in the United States, regardless of the country of 
origin of the cattle. Therefore, the action requested by the commenter 
is already included as a requirement in USDA regulations for any cattle 
30 months of age or older that would be imported from Canada.

Ports of Entry

    Some commenters addressed the regulations that have required that 
live bovines imported from Canada enter the United States only through 
ports of entries listed as authorized ports in Sec.  93.403 of the 
regulations. Some commenters expressed concern about the ability of the 
ports to handle shipments from Canada, while other commenters requested 
that the list of authorized ports be expanded.

Authorized Ports of Entry

    Issue: Several commenters stated that the proposed rule should not 
be implemented until sufficient personnel, quarantine facilities, and 
testing capabilities are available at the U.S.-Canadian border to 
monitor imports and detect suspect animals.
    Response: APHIS regulations require that live ruminants imported 
into the United States from Canada come through the border ports listed 
in Sec.  93.403(b) (except as provided in special cases in Sec.  
93.403(f)). APHIS lists ports in Sec.  93.403(b) only after determining 
that they have sufficient personnel and facilities to accommodate 
importations of live animals from Canada.

Border Ports in Alaska

    Issue: Several commenters noted that none of the border ports 
listed in Sec.  93.403(b) are on the border of Alaska and Canada and 
requested that the regulations provide for such a border port.
    Response: The volume and frequency of live animal imports through 
the ports listed in Sec.  93.403(b) justifies making Federal inspectors 
available on a regular basis. As noted above, Sec.  93.403(f) of the 
regulations provides for the designation by the Administrator of other 
ports in special cases as necessary.
    Historically, the volume and frequency of imports of ruminants from 
Canada directly into Alaska has not made it resource-effective to 
provide the Federal inspectors for such importations on a regular 
basis. Imports of bovines from Canada into Alaska under this rule will 
continue to be handled by special arrangements on an as-needed basis.

[[Page 53349]]

    For the reasons discussed above, we are making no changes based on 
the comments.

Blood and Blood Products

    Paragraph (a) of Sec.  94.18 lists regions from which imports of 
ruminants and ruminant products are prohibited or restricted because of 
BSE. Those regions in which BSE is known to exist are listed in Sec.  
94.18(a)(1); those regions that present an undue risk of introducing 
BSE into the United States because their import requirements are less 
restrictive than those that would be acceptable for import into the 
United States and/or because the regions have inadequate surveillance 
are listed in Sec.  94.18(a)(2); those regions that present a minimal 
risk of introducing BSE into the United States via live ruminants and 
ruminant products and byproducts are listed in Sec.  94.18(a)(3).
    The requirements for the importation of blood and blood products 
from BSE minimal-risk regions have been the same as the requirements 
for importation of blood and blood products from other regions listed 
in Sec.  94.18(a)--only serum and serum albumin have been eligible for 
importation. In our January 2007 proposal, we proposed to allow the 
importation of blood and additional blood products from BSE minimal-
risk regions provided certain conditions were met regarding the health 
of the animal from which the blood or blood products were derived, or--
in the case of blood collected from a fetal calf--the health of the 
dam; the method of slaughter; the process of collection of blood; and 
certification of compliance with the regulations.
    We received comments regarding the importation of bovine blood and 
blood products from BSE minimal-risk regions. Most of the commenters 
addressing this topic expressed concern regarding such importation, 
while others sought clarification as to allowable methods of collection 
of bovine blood intended for importation as blood or blood products 
into the United States.
    Issue: Several commenters stated that the regulations should not 
allow the importation of cattle blood for use as animal feed. One 
commenter stated that a number of studies have shown prion transmission 
through blood, that there is evidence that TSE diseases are capable of 
crossing the species barrier, that the EU has banned all animal protein 
except meat and eggs from use in feed for any animal that enters the 
human food chain and the United States should do the same, and that 
what the commenter referred to as the EC report on the assessment of 
BSE risk in the United States specifically condemned the practice of 
intraspecies recycling of ruminant blood and blood products. Some 
commenters specifically expressed concern about the potential use of 
blood protein as a milk replacement or as animal feed, and the 
production of spray-dried blood plasma or blood meal for use in feed.
    Response: As we discussed in detail in our risk assessment, in 
experiments examining tissues from BSE-infected cattle, no BSE 
infectivity was demonstrated in cattle blood or any tested derivatives 
(EC SSC 2002). Also as discussed in our risk assessment, the Scientific 
Steering Committee of the European Commission concluded that the 
finding of BSE infectivity in the blood of sheep could not be 
extrapolated to BSE in cattle (EC SSC 2002a). Further, the available 
evidence indicates that TSEs in other species, when found in the blood, 
are localized primarily to the cellular fractions. Although BSE has 
never been detected in any bovine blood or blood product, we expect 
even further risk reduction after removal of cellular fractions in the 
preparation of the most commonly imported bovine blood commodities. In 
addition, the mitigations included in this rule help prevent 
contamination of bovine blood and blood products with infectious 
tissues such as SRMs. Thus, there is no reason to prohibit the 
importation of cattle blood for use in animal feed. (We note that FDA 
has responsibility for determining which materials may be used in 
animal feed.) Finally, as discussed in our risk assessment, infection 
with BSE via the oral route is less efficient than by subcutaneous or 
intramuscular injection. Given that we have concluded that there is a 
negligible risk for exposure to bovine blood and blood products via the 
injectable route, the same conclusion holds for exposure via the oral 
route.
    Issue: One commenter cited a report (Castilla et al., 2005) 
regarding the first detection of scrapie prions in hamster blood, using 
a biochemical technique called protein misfolding cyclic amplification 
(PMCA).
    Response: APHIS is making no changes in response to this comment. 
The study cited by the commenter does not present evidence about BSE 
infectivity in bovine blood. The cited study presents a technique for 
the rapid amplification and detection of scrapie prions in hamster 
blood. The study is notable because the novel detection method could be 
useful in the development of diagnostic methods. Previously, only the 
prion concentration in the brain and some lymphoid tissues was high 
enough for detection by routine biochemical detection.
    However, APHIS does not assume that finding the presence of 
abnormal prion protein in a given tissue, especially at low levels, is 
equivalent to demonstrating infectivity of the tissue. APHIS notes that 
there are very sensitive bioassays in live animals for determining the 
infectivity of various tissues, such as that for BSE using 
intracerebral inoculation of transgenic mice expressing the bovine PrP. 
These methods, recently used by authors of the cited study and others 
(Espinosa et al., 2007; EC SSC 2002) have reliably determined that, 
unlike sheep, mouse, and hamster blood, bovine blood from BSE-infected 
animals does not have demonstrable infectivity.
    Issue: One commenter stated that the reference APHIS used in its 
risk assessment in discussing the lack of TSE infectivity in bovine 
blood--the European Commission Scientific Steering Committee report, 
2002--is dated.
    Response: We note that, in addition to the 2002 European Commission 
Scientific Steering Committee report the commenter refers to, a more 
recently published study (Espinosa et al., 2007) provides evidence of 
lack of TSE infectivity in cattle blood. The 2007 study found that 
orally inoculating asymptomatic cattle with BSE resulted in BSE 
infectivity restricted to the nervous system, Peyer's patches, and 
tonsils, as had been reported previously for clinically affected 
cattle. The study involved collection of tissue at 20, 24, 27, 30, and 
33 months post-challenge. Infectivity in brainstem and sciatic nerve 
was detectable only after 27 months, whereas Peyer's patches and 
tonsils were positive at every time point tested. Blood, urine, spleen, 
and skeletal muscle were negative for detectable infectivity throughout 
the study, using the very sensitive bioassay, intracerebral inoculation 
of transgenic mice expressing the bovine PrP, to assess infectivity.
    Issue: In order to guard against BSE contamination of blood 
intended for importation into the United States from BSE minimal-risk 
regions--or blood products derived from such blood--we proposed to 
require that the blood be collected in a closed system (in which the 
blood is conveyed directly from the animal in a closed conduit to a 
closed receptacle) or in an otherwise hygienic manner that prevents 
contamination of the blood with SRMs.
    Several commenters stated that, because of current line speeds in 
beef slaughter facilities, a closed collection

[[Page 53350]]

system is not practical and would be cost prohibitive for production of 
spray-dried blood plasma or blood meal. The commenters stated that 
industry associations of both renderers and spray-dried blood and 
plasma producers in the United States and Canada have developed and 
implemented guidelines and a code of practice designed to minimize the 
risk of contamination. One of the commenters stated that the 
manufacture of spray-dried blood products involves concentration of the 
liquid plasma with reverse osmosis or ultra-filtration, followed by 
atomization of the concentrated liquid in a heated drying container. 
According to the commenter, because the filtration and spray drying 
equipment will operate inefficiently if the feed liquid contains 
particulate material, a number of pre-filtration steps to remove 
particulate contamination are included in the production of spray-dried 
blood products. The commenter stated that the combination of the 
filtration system with manufacturing standards results in a system that 
meets the requirements of the regulations for collection ``in an 
otherwise hygienic manner that prevents contamination of the blood with 
SRMs.''
    Several other commenters recommended that the regulations 
specifically provide for the adoption of alternative, less restrictive 
mitigation measures should the Administrator determine they are 
scientifically justified.
    Response: As noted above, our proposed rule provided for collection 
in an otherwise hygienic manner that prevents contamination of the 
blood with SRMs, in lieu of using a closed system for the collection of 
blood. APHIS will determine whether an alternative process collects 
blood in a hygienic manner that prevents contamination of the blood 
with SRMs upon request by a party that such a determination be made. 
The request for determination must include a description of the 
proposed alternative method of collection.
    Based on information received from the industry and an evaluation 
of industry capabilities, APHIS would consider the following to be an 
example of an acceptable alternative collection process at a slaughter 
facility: After the animal has passed ante-mortem inspection and is 
stunned, a long midline cut is made in the skin on the ventral part of 
the neck. A specially designed bucket--with two barbs that allow it to 
hang on the hide and that has been treated with anticoagulant prior to 
use--is inserted into the cut, so that the opening of the bucket, an 
oval-shaped area that conforms to the shape of the cut, is essentially 
inside the skin. As the animal moves down the line, another cut is made 
with a clean knife inside the skin opening, cutting the arteries and 
veins through the thoracic inlet for exsanguinations. The carcass 
travels down the rail while the blood drains. The bucket is 
mechanically removed by a conveyor at the end of this line. The 
conveyor carries the bucket into a separate room (separate from the 
kill floor), and empties the bucket into a vat with a screen to pick 
out any clots. The blood in the vat is then centrifuged, and the cells 
are piped to a dryer in another part of the plant, while the plasma is 
held in large refrigerated vats prior to transfer to another processing 
facility. The empty bucket travels through a pre-wash that removes any 
remaining blood, then through a disinfectant wash. Before reentering 
the collection process, the cleaned and disinfected bucket is treated 
with a measured amount of anticoagulant.
    For the reasons discussed above, we are making no changes based on 
these comments to the proposed requirements for importing blood or 
blood products.

Small Intestine

    The regulations in Sec.  94.19 have required that meat, meat 
byproducts, and meat food products derived from bovines that have been 
in a BSE minimal-risk region be derived from bovines from which the 
SRMs and the small intestine were removed at slaughter. The regulations 
at Sec.  95.4(g) have applied this same requirement to offal derived 
from bovines from BSE minimal-risk regions. Section 94.0 defines SRMs 
as ``those bovine parts considered to be at particular risk of 
containing the bovine spongiform encephalopathy (BSE) agent in infected 
animals, as listed in the FSIS regulations at 9 CFR 310.22(a).''
    The regulations require removal of the entire small intestine, even 
though only part of the small intestine (the distal ileum) has been 
determined to be an SRM, to ensure removal of the distal ileum.
    In our January 2007 proposed rule, we proposed to remove the 
requirements for removal of the entire small intestine. We proposed, 
instead, to require removal of 80 inches of the uncoiled and trimmed 
small intestine, as measured from the cecocolic junction, unless the 
processing establishment has demonstrated that an alternative method is 
effective in ensuring complete removal of the distal ileum. We 
explained that this proposed change is consistent with the definition 
of SRMs in the FSIS regulations at 9 CFR 310.22(a).
    Some commenters who addressed the topic of the removal of the 
distal ileum and other parts of the small intestine requested that the 
regulations be made more stringent than at present, while others 
expressed the view that our proposed regulations were too restrictive.
    Issue: Several commenters addressed our proposed change regarding 
removal of the small intestine. One commenter recommended not only that 
the regulations continue to require the removal of the small intestine, 
but that we require that the large intestine be removed as well. The 
commenter stated that the European Commission Scientific Steering 
Committee stated that, because slaughterhouse contamination of other 
intestinal areas with matter from the distal ileum cannot be avoided, 
it is prudent to remove the entire small and large intestines. 
Additionally, stated the commenter, the International Review Team (IRT) 
that issued a report to the U.S. Secretary of Agriculture in February 
2004 called for the banning the entire intestine--from anus to 
pylorus--from human and animal food, from cattle of any age.
    Response: The issue of how much of the intestines should be removed 
to ensure removal of the distal ileum to prevent contamination with the 
BSE agent was also raised in response to rulemaking documents published 
in the Federal Register by FSIS and FDA. The agencies' responses to 
those comments were published in interim final rules published in the 
Federal Register on September 7, 2005. (FSIS Docket No., 03-025IFA, 70 
FR 53043-53050, and FDA Docket No. 2004N-0081, 70 FR 53063-53069). We 
concur with FSIS and FDA that, although the EU prohibits the entire 
intestine from use in food, the data we are aware of indicating BSE 
infectivity along the entire intestine is from other species, and may 
not represent the distribution of infectivity in cattle infected with 
BSE, as evidenced by studies with bovine tissues.
    In cattle, infectivity has been found in the distal ileum in tissue 
assay from cattle experimentally given BSE (Wells et al., 1994). In 
such cattle, positive Peyer's patches were found by 
immunohistochemistry only in the distal ileum, and in cattle with 
naturally occurring and experimental BSE, positive myenteric plexus 
neurons were found only in the distal ileum (Terry et al., 2003). The 
duodenum of cattle experimentally given BSE has not demonstrated 
infectivity when tested by mouse bioassay and has been negative

[[Page 53351]]

for the presence of abnormal prions when examined by 
immunohistochemistry during all stages of the pathogenesis of the 
disease (Wells, 1994). Few samples of jejunum have been tested, but 
those that have been tested were negative for the presence of abnormal 
prions when examined by immunohistochemistry (Terry et al., 2003). In a 
bioassay of tissues from cattle with naturally occurring BSE, no 
infectivity was found in the splanchnic nerve, rumen, omasum, abomasum, 
proximal small intestine, proximal colon, distal colon, and rectum, or 
in the distal small intestine (EU SSC 2002).
    The study by Terry and others indicated that the myenteric plexus 
of the distal ileum contained some abnormal prion protein in neurons 
(Terry et al., 2003). Since the myenteric plexus extends throughout the 
small intestine, we acknowledge the possibility that infectivity might 
exist in the myenteric plexus of the jejunum or the duodenum. However, 
if infectivity in intestinal tissues (other than distal ileum) exists, 
it is below the level of detection by both mouse and cattle bioassay. 
Given the relative efficacies of these experimental modes of 
transmission compared to oral exposure at doses estimated to have 
occurred in the field, we conclude that intestine other than the distal 
ileum is highly unlikely to contain epidemiologically significant 
levels of infectivity, if any infectivity is present at all.
    We do not agree that slaughterhouse contamination of other 
intestinal areas with matter from the distal ileum cannot be avoided. 
FSIS is responsible for ensuring the adequacy and effectiveness of 
procedures for removing the distal ileum in slaughterhouses. The FSIS 
regulations require that establishments develop, implement, and 
maintain written procedures for the removal, segregation, and 
disposition of SRMs, and that they incorporate these procedures into 
their HACCP (Hazard Analysis and Critical Control Point) plans, 
sanitation standard operating procedures, or other required programs (9 
CFR 310.22(d)(1)). These procedures must ensure that SRMs, including 
the distal ileum, are completely removed from the carcass, segregated 
from edible products, and disposed of in an appropriate manner as 
prescribed by 9 CFR 314.1 and 9 CFR 314.3 (i.e., used for inedible 
rendering, incinerated, or denatured). Regions wishing to export meat 
and meat products to the United States must follow processing practices 
equivalent to those of FSIS.
    With regard to the IRT report referenced by the commenter, the 
recommendation for removal of the entire intestine, from anus to 
pylorus, was meant to apply in the United States only if the risk of 
BSE had not been determined to be minimal, based on aggressive 
surveillance. Aggressive surveillance conducted in both the United 
States and Canada indicate a very low prevalence of BSE. Therefore, the 
recommendation of the IRT for removal of the entire intestine of all 
cattle does not apply. As discussed above, scientific evidence does not 
support the designation of the entire intestine as an SRM.
    Issue: Several commenters stated that the regulations should 
require that only the distal ileum be removed, rather than an 
additional 80 inches of small intestine. The commenters stated that 
APHIS has not established that it is necessary to excise so much 
additional intestine. At a minimum, stated the commenters, the 
regulations should allow the Administrator to approve effective 
alternatives in ensuring complete removal of the distal ileum.
    Response: As discussed in our proposed rule, removal of the distal 
ileum as well as an additional portion of the small intestine is 
consistent with FSIS and FDA requirements to ensure removal of the 
distal ileum. APHIS concurs with FSIS and FDA that, unless demonstrated 
otherwise, to ensure complete removal of the distal ileum, it is 
prudent to require removal of 80 inches of the uncoiled and trimmed 
small intestine as measured from the cecocolic junction. We concur that 
this standard will ensure removal of the distal ileum despite 
differences in length of the intestinal tract or its segments between 
breeds or variations from animal to animal of the same breed. However, 
we recognize, as do FSIS and FDA, that alternative means of ensuring 
removal of the distal ileum may exist, and current APHIS regulations 
provide for such alternative means.
    For the reasons discussed above, we are making no changes based on 
these comments to the proposed requirements regarding removal of part 
of the small intestine.

Bovine Tongue

    Issue: One commenter stated that USDA's assumption that removal of 
a fraction of the small intestine and the tonsils removes any potential 
for transmission to humans is unjustified, given that APHIS has not 
evaluated the potential for contamination of tongue with tonsil tissue. 
The commenter also stated that APHIS claims this possibility is 
eliminated by current slaughter techniques, and stated further that 
such an assumption is contradicted by facts (i.e., scientists who 
examined over 250 bovine tongues intended for human consumption found 
tonsillar tissue in the vast majority--in some cases, ``even after the 
most rigorous trimming of the root of the tongue'' (Wells et al., 
2005). The commenter stated that APHIS cannot simply assume this risk 
away by stating, without record support, that it is eliminated.
    Response: We are making no changes based on the comment. Wells et 
al. (2005) state the following:

    However, the trace level of infectivity so far detected in 
tonsillar tissue and the localization of the lingual tonsillar 
lymphoid tissue, together with the current SRM legislation for the 
removal of tonsil from cattle carcasses and the low and diminishing 
prevalence of BSE in the UK suggest that the risk of human exposure 
to infected tonsil is now remote. It seems likely that under these 
circumstances any additional trimming of the tongue would result in 
an immeasurable reduction in the risk. * * *

    In other words, the study cited by the commenter does not present a 
strong case for additional risk measures. The study, in fact, indicates 
the opposite conclusion.
    Moreover, even before the SRM requirements were implemented in 
January 2004, FSIS did not consider tonsil to be edible tissue--it was 
previously required to be removed. As noted in FSIS Notice 50-04:

    In the preamble to 9 CFR 310.22, FSIS stated that tonsils of all 
livestock species, including cattle, were already required to be 
removed and were prohibited for use as ingredients in meat food 
products under 9 CFR 318.6(b)(6). The accepted practice for removing 
the tonsils from livestock has been to remove all visible tonsils. 
In cattle, this includes separation of the palatine tonsils and 
lingual tonsils from the tongue (in establishments that harvest the 
tongue for human food) by a transverse cut caudal (just behind) the 
last vallate papillae. * * * FSIS expected that establishments would 
continue to remove tonsils from cattle in accordance with the 
procedures that they had implemented to comply with 9 CFR 
318.6(b)(6) * * *. Establishments that slaughter cattle should have 
been following these practices before tonsils were designated as 
SRMs. (FSIS, 2004).

    APHIS' quantitative exposure model included an update that 
acknowledged the potential infectivity in tonsils and clearly added 
these as an SRM, with the acknowledgment that they could still be 
potentially available for human consumption. In fact, the output tables 
from the model runs show the potential ID50s derived from 
tonsils and available for human consumption over the 20-year period of 
the analysis. These values are obviously very low, ranging from

[[Page 53352]]

0.026 ID50s in the base case scenario to 0.16 
ID50s in sensitivity analysis 6 (in which all uncertain 
parameters were simultaneously set to their corresponding pessimistic 
level). Such very small values are not surprising given the low 
likelihood of infectivity in the tissue itself. These possible exposure 
routes were therefore explicitly modeled and not ``assumed away.'' 
Moreover, although our model predicts a vanishingly low level of 
possible human exposure via tonsils, we have not stated that the risk 
is ``eliminated,'' as was suggested in the comment.
    Issue: A number of commenters urged that, before this rule is 
implemented, a plan should be in place for the removal and mitigation 
of any potential risk factors that might arise from the introduction of 
the BSE agent into the United States because of the importation of a 
BSE-infected cow.
    Response: We are making no changes based on the comments. The 
safeguards in the United States regarding any BSE-infected cow that 
might be imported from a BSE minimal-risk region are the same that are 
in place to deal with a BSE-infected cow of any source, including any 
of U.S. origin that might be detected. These mitigations are simulated 
in the quantitative exposure model used in the risk assessment for this 
rule.
    The primary animal-health mitigation measure is the feed ban 
implemented by the FDA in 1997. This feed ban is the most important 
measure to prevent the transmission of disease to cattle. In addition 
to the regulatory restrictions imposed by the feed ban, other industry 
practices--such as rendering processes that inactivate a significant 
proportion of BSE infectious agent present in raw material--and 
biological processes--such as age susceptibility to infection--also 
help to mitigate the transmission of disease to animals.
    Public or human health protective measures are maintained by both 
the FSIS and the FDA. The most important public health protective 
measure is the removal from the human food supply of SRMs. Other 
controls include prohibiting air-injection stunning of slaughter 
cattle; requiring additional process controls in advanced meat-recovery 
systems; forbidding the use of mechanically separated meat in human 
food; and prohibiting nonambulatory disabled cattle from the human food 
chain. Additionally, protection from BSE and other disease is achieved 
through ante-mortem inspection of slaughter cattle and the exclusion of 
animals with any clinical signs of neurological disease or other 
abnormalities.
    If a BSE-positive bovine were identified in the United States, 
APHIS would lead an epidemiological investigation that would include 
the tracing of birth cohorts of the infected animal. Birth cohorts are 
those animals that could have been exposed to the same feed as the 
infected animal, and include those bovines that were born on the same 
premises as the infected animal during the 12-month period immediately 
before the birth of the infected animal or during the 12-month period 
immediately after the birth of the infected animal. They would also 
include other bovines raised on the premises at the time the infected 
animal was there. Any birth cohorts located would be prevented from 
entering the human or animal feed chains. In addition to the APHIS 
epidemiological investigation, FDA would conduct an extensive feed 
investigation to help determine the potential source of the infection.
    With regard to commodities eligible for importation from BSE 
minimal-risk regions under this rule, we have concluded that such 
commodities can be imported with a negligible BSE risk to the United 
States.

The Role of States

    Several commenters discussed the role U.S. States should play 
regarding bovines imported from BSE minimal-risk regions.
    Issue: Commenters stated that CFIA and APHIS should provide the 
State veterinarian in the U.S. State that is receiving such bovines 
with all animal health and identification documentation before the 
animal is imported. Commenters requested further that the regulations 
require all importers of cattle over 30 months of age from BSE minimal-
risk regions to report all movements of the animal to the department of 
agriculture of the recipient State before the animal is moved into or 
through the State.
    Response: As noted above, the purpose of the current APHIS 
regulations with regard to BSE, and those in this rule, is to allow the 
importation into the United States of commodities that can be imported 
with a negligible likelihood of the BSE exposure and establishment in 
the U.S. cattle population as a consequence of eligible imports from 
Canada. We do not consider the extensive recordkeeping and paperwork 
requirements suggested by the commenters to be warranted or justified 
by science and are making no changes in response to the comments.
    Issue: Commenters recommended that APHIS authorize each State 
Veterinarian to ensure that the animal health and identification 
requirements of the APHIS regulations are met, and recommended further 
that, in the event the State determines noncompliance with the APHIS 
regulations, USDA support the enforcement actions of the State 
officials.
    Response: APHIS has a historical and ongoing working relationship 
with State animal health officials to protect livestock in the United 
States from both foreign diseases and diseases endemic to the United 
States. This ongoing cooperation has enabled the United States to 
protect this country's livestock from a variety of diseases, including 
BSE. It has not been necessary to specify this working relationship in 
the APHIS regulations, and we do not consider it warranted to do so for 
any one disease. However, APHIS emphasizes that it values highly its 
cooperative efforts with State animal health officials and welcomes a 
continuing exchange of information and support in carrying out our 
mutual missions.

Potential Economic Effects of the Proposed Rule

    A large number of commenters addressed the potential economic 
effects of the proposed rule. Most of these commenters expressed 
concern that the proposed rule would have an unacceptable negative 
impact on U.S. entities. Some of the commenters took issue with the 
economic analysis we conducted for our proposed rule.
    Issue: Many commenters recommended that APHIS withdraw or restrict 
implementation of this rule because of its potential negative economic 
effects on the U.S. livestock and livestock product industry, due to 
the potential significant influx of cattle from Canada over a short 
period of time. A number of commenters requested that the rule not take 
effect until USDA has developed and implemented an orderly market 
transition plan to reduce the negative effect of the rule on U.S. 
cattle producers. One commenter stated that such a plan should include 
gradually accepting imports, so as not to overload the U.S. cattle 
supply and crash those markets. Further, commenters recommended that 
APHIS delay implementation of the rule until all U.S. export markets 
that were closed due to the December 2003 detection in an imported cow 
in Washington State are reopened.
    Response: APHIS does not have the statutory authority to restrict 
trade based purely on its potential economic impact, market access 
effects, or

[[Page 53353]]

quantity of products expected to be imported. Under the Animal Health 
Protection Act, the Secretary of Agriculture may prohibit or restrict 
the importation or entry of any animal or article when the Secretary 
determines it is necessary to prevent the introduction or dissemination 
of a pest or disease of livestock. This authority has been delegated to 
APHIS.
    We note that this rule, and our January 2005 final rule, do not 
make any commodities eligible for importation from Canada that were not 
already allowed importation prior to May 2003, when a BSE-infected cow 
was diagnosed in Canada. One difference between the current situation 
and pre-May 2003, however, is that certain of the commodities that are 
now eligible for importation, or that will become eligible when this 
rule becomes effective, are subject to risk mitigating importation 
conditions appropriate to the fact that BSE has been detected in Canada 
and that we consider that country a minimal-risk region for BSE. As 
noted above, both Canada and the United States have been classified as 
controlled risk countries for BSE under the OIE guidelines. 
Additionally, even under these rules, there are some commodities (e.g., 
cattle born before March 1, 1999) that continue to be ineligible for 
importation into the United States. Nevertheless, this rulemaking and 
our January 2005 final rule represent to a great extent a return to 
trade patterns that existed between the United States and Canada for 
many years previously. As discussed in the January 2007 proposal for 
this rule, in this final rule, and in the risk assessment for this 
rule, we have determined that the commodities eligible for importation 
from Canada under this rulemaking can be imported into the United 
States under the conditions specified with a negligible BSE risk to the 
United States.
    With regard to exports markets that were closed to U.S. beef 
following the December 2003 detection of BSE in a cow of Canadian 
origin in Washington State, U.S. Government agencies are actively 
negotiating with trading partners to reestablish our export markets. 
After the 2003 detection of an imported BSE-infected cow in Washington 
State, many of the 114 nations that imported U.S. beef banned our beef 
and live animals, despite the apparent lack of scientific basis for 
such measures. The efforts of multiple U.S. Government agencies have 
succeeded in removing bans in over half of those markets, including our 
largest export market, Japan. U.S. Government agencies continue to work 
to reopen or further open markets where restrictions remain; the 
results of these negotiations are posted on the USDA APHIS Web site 
(http://www.aphis.usda.gov).
    Issue: Some commenters took issue with the economic analysis that 
we conducted for our January 2007 proposed rule. One commenter stated 
that the economic analysis ignored any multiplier effects (i.e., the 
impact of a change in the level of economic activity in one sector on 
other sectors of the economy and on households in terms of employment 
and income) that would come from the broader economic impacts on the 
beef wholesale sector.
    Response: We used the multi-sector model in our economic analysis 
to examine impacts for the major vertically linked marketing channels 
for beef and other livestock products. We estimate consumer surplus for 
the beef sector will increase by 1 to 1.3 percent at the retail level 
in scenario 3 of the economic analysis. Indirect downstream effects on 
income and employment are not modeled; however, we do not believe APHIS 
is required to analyze the impacts of regulation on every sector of the 
economy that may be indirectly affected by these changes. As in many 
regulations, opportunity costs imposed on one sector of the economy are 
often passed on to other sectors of the economy. We anticipate that 
there may be indirect economic benefits to communities where, for 
example, cull cattle imported from Canada result in increased slaughter 
plant employment. In other communities, there may be income and 
employment losses due to reduced spending by producers who face a fall 
in prices for cull cattle. These impacts are expected to be small on a 
national basis, although they may show some geographic concentration. 
Overall, the effects of this rule are expected to reflect a return to 
trade circumstances similar to those that existed prior to May 2003.
    Issue: One commenter indicated that APHIS acknowledged the 
sensitive nature of the results of the economic analysis based on the 
parameters (elasticities) used to drive the economic model and 
requested public comment on those parameter assumptions. The commenter 
stated that APHIS should have done a literature search for studies that 
report on these parameters and should have made those reported 
parameters available, in order to provide policy analysts with fuller 
knowledge to assess the accuracy of the results reached by APHIS.
    Response: APHIS agrees that this would be useful information to 
provide for those interested in the impact analysis. The two tables 
that follow summarize our overview of demand and supply elasticities 
estimated or used in published research. The referenced sources are 
identified in a footnote following the tables.\12\ The elasticities we 
use in the economic analysis fall within a reasonable range of the 
elasticities found in these various sources.
---------------------------------------------------------------------------

    \12\ Arnade, C.,and K. Jones. ``Modeling the Cattle Replacement 
Decision.'' Paper prepared for presentation at the American 
Agricultural Economics Association Meeting, Montreal, Canada, July 
27-30, 2003.
    Brester, G.W., J.M. Marsh, and V.H. Smith. ``The Impacts on U.S. 
and Canadian Slaughter and Feeder Cattle Prices of a U.S. Import 
Tariff on Canadian Slaughter Cattle.'' Can. J. Agr. Econ. 50(March 
2002), pp. 51-66.
    Brester, G.W. ``Estimation of the U.S. Import Demand Elasticity 
for Beef: The Importance of Disaggregation.'' Rev. Agr. Econ. 
18(January 1996), pp. 31-42.
    Brester, G.W., and M.K. Wohlgenant. ``Estimating Interrelated 
Demands for Meats Using New Measures for Ground and Table Cut 
Beef.'' Amer. J. Agr. Econ. 73(November 1991), pp. 1182-94.
    Marsh, J.M. ``Impacts of Declining U.S. Retail Beef Demand on 
Farm-Level Beef Prices and Production.'' Amer. J. Agr. Econ. 
85(November 2003), pp. 902-13.
    Marsh, J.M. ``Estimating Intertemporal Supply Response in the 
Fed Beef Market.'' Amer. J. Agr. Econ. 76(August 1994), pp. 444-53.
    Marsh, J.M. ``USDA Data Revisions of Choice Beef Prices and 
Price Spreads: Implications for Estimating Demand Responses.'' J. 
Agr. and Res. Econ. 17(December 1992), pp. 323-34.
    Wohlgenant, M.K. ``Demand for Farm Output in a Complete System 
of Demand Functions.'' Amer. J. Agr. Econ. 71(May 1989), pp. 241-52.

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[[Page 53354]]

[GRAPHIC] [TIFF OMITTED] TR18SE07.027

    Issue: One commenter stated that the type of ``welfare'' analysis 
APHIS used in its economic analysis is invalid because it relies upon 
the unscientific concept of interpersonal utility comparison.
    Response: We disagree. Our economic analysis does not attempt to 
make interpersonal utility comparisons. We recognize that an additional 
dollar of income provides a different level of utility to every 
individual. APHIS uses techniques that are quite standard in welfare 
and trade economics; we estimate changes in consumer and producer 
surplus that may result from projected changes in cattle and beef 
imports from Canada under different scenarios. For a given transaction, 
consumer surplus refers to the value that the purchase of the good 
provides the buyer over and above its price. Producer surplus refers to 
the value that the sale of the same good provides the seller over and 
above the lowest price at which he would have been willing to sell it.
    The estimated changes in welfare and prices are generalized across 
all entities that would take part in transactions concerning the 
particular commodity at hand, such as the purchase and sale of cull 
cattle. We make no attempt to evaluate impacts on income distribution 
or the utility gained or lost by individual market participants. In a 
transaction, the buyer and the seller both gain utility, as 
individually determined, compared to their next best alternatives. 
Otherwise the transaction wouldn't occur. But for some entities, the 
``gain'' in utility may be, in fact, a smaller welfare loss than the 
participant anticipates would be incurred without the transaction 
(e.g., selling a cull animal rather than keeping it past the optimal 
point of sale, even though the price has declined). Commodity-wide 
changes in welfare (changes in consumer and producer surplus) reflect 
the changes in utility across all buyers and sellers of the commodity.
    The common measure of value and, therefore, of changes in welfare 
is, of course, the dollar. Our analysis appropriately uses changes in 
consumer and producer surplus, expressed in dollars, to evaluate net 
benefits of this rule and other scenarios considered. As pointed out in 
the Office of Management and Budget's Circular A-4, a distinctive 
feature of benefit-cost analysis is that both benefits and costs are 
expressed in monetary measures, which allows a common measure for 
evaluation of different regulatory options.\13\
---------------------------------------------------------------------------

    \13\ Office of Management and Budget, Circular No. A-4, 
Regulatory Analysis, September 17, 2003. http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf
---------------------------------------------------------------------------

    Issue: One commenter stated that the economic analysis for the 
proposed rule is invalidated by its assumption that import numbers will 
be exogenous, rather than determined within the context of a dynamic 
North American livestock market.
    Response: APHIS disagrees. We agree that the North American 
livestock market is a dynamic system, with the interplay of changing 
prices and changing supply and demand quantities continually redefining 
market equilibria. The projected imports from Canada may be exogenous 
to the particular model we used to estimate domestic impacts; however, 
they are derived from USDA baseline projections and anticipated market 
changes that reflect the fluidity of interacting markets. In other 
words, the impacts were not modeled as external exogenous shocks, but 
rather as rational responses to changing market conditions. We also 
note that every model is an abstraction from reality that relies upon 
selected exogenously determined values and parameters. Our import 
projections are

[[Page 53355]]

well based in theory and market considerations. Imports of Canadian 
cull cattle will be newly reestablished by the rule, and effects for 
the other modeled commodities will derive from the resumption of the 
cull cattle imports. The principal model we use to evaluate expected 
effects of the rule is a net trade model, and its operation is driven 
by projected changes in net trade.
    Issue: One commenter stated that our economic analysis overstates 
consumer benefits associated with the availability of cull cattle for 
slaughter in the United States, because it does not adequately account 
for substitution among the modeled products in both the United States 
and Canada.
    Response: Consumer welfare benefits are expected to be gained under 
the rule by buyers of processing beef at the wholesale level. Lean 
processing beef from cull cattle and trimmings from fed beef are 
complementary goods that are combined to produce ground beef. At the 
level of the retail shopper, there is a degree of substitution between 
ground beef and fed beef cuts, but this relationship is not expected to 
significantly influence the estimated consumer benefits attributable to 
the rule.
    As part of the economic analysis for the final rule, we simulate 
substitution among livestock products in response to relative price 
changes. The simulations yield measures of consumer welfare changes at 
the retail level. Results of this analysis indicate that, with the rule 
under scenario 3 as discussed in our economic analysis and in the 
summary of that analysis in this document (entry of Canadian cattle 
born on or after March 1, 1999, and resumption of imports of beef from 
Canadian cattle slaughtered at 30 months of age or older), consumer 
surplus for the beef sector at the retail level will increase by 1 to 
1.3 percent compared to a 2006 baseline.
    Issue: One commenter stated that, based on normal culling rates, 
the January 2007 herd size, the modernization and expansion of Canada's 
slaughter plants, and the increased use of Canadian beef in the 
Canadian domestic market, the number of animals that might be available 
for export is considerably lower than the number estimated by USDA. The 
commenter calculated that the number of older, age verified, beef and 
dairy animals that might be eligible for export would total about 
471,000 head annually, consisting of approximately 250,000 dairy cows, 
154,000 beef cows, and 67,000 bulls. The commenter noted that the 
estimate of 471,000 head should be viewed as an upper bound and that, 
if confirmation of an animal's age proves to be a complex procedure, 
that number would be reduced.
    One commenter stated that, in assessing the potential economic 
effects of this rulemaking, the use of any historical references 
regarding trade flows and regional basis levels to assess potential 
impacts are not likely to be of much use, due to changes in cattle 
usage. The commenter stated that the vast majority of Canadian cull 
cows and bulls will be converted into beef in Canada, and, after 
subtracting the elimination of the supplemental tariff rate quota (TRQ) 
supplies, the balance could be exported to the United States depending 
on the influence of the exchange rate. (``TRQ'' is the total annual 
quantity of a commodity that can be imported at a lower tariff rate, 
excluding imports from NAFTA countries. Canada's supplemental TRQ beef 
supplies were quantities of beef above the tariff rate quota that were 
allowed by Canada to enter at the lower tariff rate. In eliminating 
supplemental TRQ certificates--that is, by not allowing additional beef 
imports at a lower tariff rate, Canada is relying to a greater extent 
on domestic production and less on imports.)
    Response: We have considered these observations carefully and 
reassessed the proposed rule import projections and, as a result, have 
revised our economic analysis based on a smaller quantity of cull 
cattle projected to be imported from Canada. Although the modernization 
and expansion of Canada's slaughter plants and increased reliance on 
Canadian beef in the Canadian domestic market will tend to dampen cull 
cattle imports from that country, we expect the major reason for a 
smaller number of imports will be the requirement that the cattle be 
verified as having been born on or after March 1, 1999. In the 
preliminary regulatory impact analysis (RIA) we conducted for our 
January 2007 proposed rule, we projected that cull cattle imports from 
Canada in 2008, for example, would total 657,000 head (586,000 cows and 
71,000 bulls and stags). In scenario 3 of the final RIA, however, we 
are projecting cull cattle imports in 2008 totaling 75,000 head (63,000 
cows and 12,000 bulls and stags). We believe that the commenter who 
estimated that there would be approximately 471,000 older cattle 
eligible for import from Canada, and who acknowledged that number was 
an upper bound estimate, did not fully consider the extent to which the 
age verification requirement would reduce the number of eligible 
cattle. Of the cull cattle that might be imported by the United States 
if there were no age restriction and no age verification requirement, 
only about one-fourth are expected to be eligible for importation in 
2008 under this rule, and only about one-half may be eligible by 2012.
    Issue: One comment stated that APHIS did not provide an explanation 
in its economic analysis for the different percentages of cattle over 
30 months of age and of such cattle plus beef from cattle over 30 
months of age assumed to displace other processing beef imports.
    Response: We agree that it is reasonable to expect, for all of the 
scenarios set forth in the economic analysis, that a consistent 
percentage of Canadian imports across the scenarios would displace 
other imports. We have revised the final RIA accordingly. In this final 
rule, we estimate that 25 percent of cull cattle imports from Canada 
(scenarios 1 and 2 in our economic analysis) and 25 percent of cull 
cattle and beef derived from cattle 30 months of age or older (OTM 
beef) from Canada (scenario 3 in our economic analysis) will displace 
U.S. processing beef imports from elsewhere. The estimate of 25 percent 
comes from simulations of the multi-sector model and takes into account 
interactions of the processing beef sector with the beef cattle and 
dairy cattle sectors. The model allows cattle prices to adjust to an 
increase in beef imports from one source (in this case, cull cattle and 
OTM beef imports from Canada), spreading the market response across 
both beef and cattle. This interaction dampens the beef price decline 
and reduces the amount of displacement below that would be expected to 
occur by considering only the market for processing beef. We also 
examine the sensitivity of the impacts to changes in the quantities of 
cull cattle and processing beef imported from Canada that displace 
processing beef from elsewhere: The RIA presents results assuming 50 
percent of the imports from Canada displace imports from elsewhere as 
well as results assuming none of the imports from Canada displace other 
imports.
    Issue: Several commenters, in addressing the potential economic 
effects of this rulemaking, stated that the time of year a final rule 
would go into effect is an extremely important variable in assessing 
its initial economic impact. One commenter stated that U.S. cull cow 
marketings are highly seasonal because the majority of calves are born 
in the spring and the decisions to retain cows are generally made 
during the fall. As a result, the months of October, November, 
December, and January are typically lowest for cull cow prices. Another 
commenter stated that implementation of the rule in the fall of

[[Page 53356]]

2007 (post-weaning) would likely result in a larger impact on U.S. cull 
cow prices in the very short term.
    Response: We agree with the commenters that, in the short term, the 
timing of the resumption of imports of cull cattle and processing beef 
from Canada could have an impact on producers' monthly revenues. 
Historically, cull cow slaughter in the United States is highest in the 
months of October, November, December, and January. As the commenters 
noted, because of this, cull cow prices are typically lower in these 
months. Limited data prevent analysis on a monthly basis of price 
changes in response to projected cull cattle imports from Canada. 
However, we do acknowledge that, because of the larger number of cull 
cattle marketed per month, during October through January, a slight 
price decline during this period would result in larger total monthly 
revenue losses for U.S. producers than during the other months of the 
year. This seasonal difference in monthly revenue losses would not be 
large on an annual basis.
    This outcome is demonstrated in research conducted at Montana State 
University (Brester et al., 2007). This study examined effects of 
additional cull cattle slaughter using two scenarios: One in which 
Canadian cull cattle imports return to pre-2003 levels and do not 
displace beef imports from other countries, and a second in which 50 
percent of cull cattle and processing beef imports from Canada displace 
beef imports from Uruguay. The changes in U.S. cull cattle prices 
estimated for these two scenarios are declines of $1.55 per cwt and 
$0.78 per cwt, respectively. The average of the price changes reported 
in the Montana State study, $1.17 per cwt (2.5 percent of the 2006 
average U.S. cull cow price of $47.56 per cwt), would correspond to 25 
percent of imports from Canada displacing processing beef imports from 
other countries, which is the percentage share used in the economic 
analysis for this final rule.
    As reported by Brester et al. for the period, 2000-2006, monthly 
cull cattle sales averaged 488,000 head, October through January, 
compared to an average of 434,000 head per month, February through 
September. Based on the Montana State study results, a 25 percent level 
of displacement would correspond to a decrease in total monthly revenue 
for cow-calf producers of $5,956,500, October through January, and 
$5,297,000, February through September. In other words, there would be 
an additional revenue loss of $659,000 (12 percent) per month, October 
through January.
    We project in our economic analysis a baseline for beef and dairy 
cow slaughter in 2008 totaling 5,084,000 head, and a nominal 2008 price 
of $54.19 per cwt. Based on an average live slaughter weight of 1,050 
pounds, total baseline gross revenue from the sale of cull cows in 2008 
would be $2.89 billion. The increase in producer losses because of 
increased cull cattle sales occurring during the months of October 
through January, rather than during the months of, February through 
September, based on the Montana State study results, would total less 
than 0.1 percent of the projected baseline annual revenue from cow 
slaughter.\14\
---------------------------------------------------------------------------

    \14\ An additional revenue loss of $659,000 per month, October 
through January, multiplied by the four months, yields an additional 
annual revenue loss of $2,636,000. This amount divided by the total 
baseline revenue from cow slaughter projected in the regulatory 
impact analysis of $2,892,770,580 (5,084,000 cows slaughtered, at a 
price of $54.19 per cwt and an average weight of 1,050 pounds) 
yields an additional revenue loss on an annual basis of 0.09 
percent.
---------------------------------------------------------------------------

    While we recognize that the timing of the resumption of cull cattle 
imports from Canada may influence the size of the short-term impacts 
for producers, differences in revenue losses due to the timing of the 
implementation of the rule are considerably smaller when considered on 
an annual basis. Our analysis is in terms of annual cattle import 
projections and, therefore, yields annual price and welfare effects. 
The within-year distribution of effects is smoothed in the annual 
estimate.
    Issue: Many commenters addressed the issue of the potential 
economic impact on U.S. cattle producers should a bovine of Canadian 
origin be diagnosed in the United States as BSE-infected. A number of 
the commenters expressed general concern regarding such a potential 
impact, and suggested that APHIS' analysis of the potential economic 
effects of the proposed rule was incomplete because it did not consider 
such impacts. Commenters stated that such impacts have been large in 
other countries and could overwhelm the effects estimated by APHIS if a 
BSE-infected animal imported into the United States under the 
provisions of this rule caused the spread of BSE in the United States, 
and that a comprehensive economic analysis should include consideration 
of the demand reactions that would be triggered by identification of 
additional Canadian-born BSE cases in the United States, even at the 
low levels projected in APHIS' risk assessment.
    Other comments stated that the cost associated with the projected 
importation of up to 160 BSE-infected cattle into the U.S. (based on 
APHIS' estimate for the 95th percentile of confidence) over 20 years, 
or the projected 2 to 20 U.S.-born infected cattle, should have been 
considered. Several commenters expressed concern that the existence of 
21 to 180 cases of BSE-infected animals could substantially undercut 
demand for beef, as it has done in Europe, or dairy, if the public 
begins to identify BSE with the older dairy breeding stock that are 
most at risk of manifesting the disease.
    A number of commenters expressed concern regarding the potential 
economic impact of the detection in the United States of a Canadian-
born BSE-infected cow on U.S. export markets. Commenters stated that 
the reaction of the beef markets to the first U.S. case of BSE--despite 
that cow's being of Canadian origin--demonstrates the very substantial 
potential costs to U.S. cattle industries of introducing even a limited 
number of infected animals into the U.S. herd. Commenters stated that 
APHIS should examine such potential economic impacts.
    Response: Expected economic impacts if new cases of BSE were to 
occur in the U.S. cattle population because of the rule are addressed 
in the consequence assessment portion of the risk assessment we 
conducted for this rulemaking. The consequence assessment notes that 
effects of BSE include a variety of costs. Some costs are long-term; 
others are one-time costs uniquely associated with new cases.
    The major long-term cost for the United States due to the diagnosis 
of BSE in a cow of Canadian origin in Washington State in December 2003 
has been reduced access since then to beef export markets. Principal 
Asian markets, in particular, remain largely restricted. In 2003, the 
value of U.S. exports of beef and beef by-products (as measured by the 
33 ``beef only'' Census Bureau categories) totaled over $3.9 billion, 
of which the value of sales to Asian markets totaled $2.4 billion. In 
2004, these totals had fallen to $863 million and $16 million, 
respectively. In 2006, the value of U.S. beef and beef by-product 
exports worldwide was $2.1 billion, and exports to Asia were valued at 
$197 million.\15\
---------------------------------------------------------------------------

    \15\ Compiled by APHIS using data from the Department of 
Commerce, U.S. Census Bureau, Foreign Trade Statistics.
---------------------------------------------------------------------------

    Trade impacts tend to decline over time as exporting and importing 
countries find ways to resume mutually beneficial trade while 
maintaining the safety of the beef supply. The OIE has developed 
international science-based

[[Page 53357]]

animal health standards to permit safe international trade in beef from 
countries that have BSE, based on the risk level of such countries. The 
OIE has classified both the United State and Canada as controlled risk 
countries for BSE.
    We anticipate that the economic impact of any additional cases of 
BSE-infected cows imported from Canada will likely be minimal. As noted 
above, after the 2003 detection of BSE in Washington State, many of the 
114 nations which imported U.S. beef banned our beef and live animals, 
but over half--including our largest export market, Japan--have resumed 
importing U.S. beef (USDA 2006).\16\ The joint U.S.-Japan press 
statement for resuming trade in beef and beef products after market 
closures in response to finding BSE in the United States noted that the 
United States has a ``robust'' food safety system, and stated that 
``identification of a few additional BSE cases will not result in 
market closures and disruption of beef trade patterns without 
scientific foundations'' (USDA 2004). Adherence to science is 
imperative to expanding trade opportunities and maintaining existing 
market access. Continued import bans by other countries without 
sufficient scientific basis to warrant such measures, and maintained 
without adequate assessment of specific risks, may not be consistent 
with international trade obligations, and U.S. Government agencies 
continue to work to reopen such markets.
---------------------------------------------------------------------------

    \16\ The temporary closure of the U.S. export market to Japan in 
January 2006 was in response to a specific commodity concern and not 
to the likelihood of BSE infection in the U.S. herd.
---------------------------------------------------------------------------

    One of the potential incremental costs of the detection of BSE in 
an imported cow is the regulatory expense of investigating such cases 
and paying indemnity for animals that are destroyed. Based on the U.S. 
experience with native BSE cases that have been detected, the 
regulatory costs per case total approximately $250,000 for 
epidemiological investigations and indemnification of depopulated 
animals.
    The potential domestic market effects of any new cases of BSE are 
difficult to predict. However, as described in the consequence 
assessment in our risk assessment, there is little reason to expect 
that additional U.S. cases of BSE would have a significant impact on 
U.S. beef consumption, based on past experience.
    Although the first U.S. discovery of BSE, a cow of Canadian origin, 
resulted in major restrictions on U.S. beef exports, that case and 
subsequent cases have not, to use the commenter's term, ``substantially 
undercut'' U.S. demand for beef or dairy products. Studies show that 
any negative consumer response to the discoveries of BSE in Canada and 
the United States in May and December 2003, respectively, was neither 
significant nor long-lasting.
    Consumer opinion surveys as summarized by Coffey et al. (2005) 
indicated that between 14 and 29 percent of respondents reported 
reducing their beef consumption. However, as Kuchler and Tegene (2006) 
point out, survey responses may systematically differ from actual 
market behavior. Coffey et al. found that, in the months following the 
December 2003 BSE discovery, consumer demand for beef increased.
    Vickner, Bailey, and Dustin (2006) analyzed weekly grocery store 
purchases, from May 9, 2004, to May 1, 2005. The authors studied the 
impact of BSE announcements on consumer demand for beef in Utah over 
this time period and found that Utah consumers were not responsive to 
BSE announcements during that period. Kuchler and Tegene found similar 
results on a national scale. The authors studied three separate 
markets, including fresh beef from grocery store meat counters, frozen 
beef, and frankfurters. The study concluded that the announcement of 
the finding of BSE in a Washington State cow may have reduced purchases 
of fresh and frozen beef over a 2-week period, but had no impact on 
purchases of frankfurters. A similar announcement for the finding of 
BSE in Canada had no noticeable impact on beef purchases in the United 
States.
    Although various consumer studies have concluded that discovery of 
additional cases of BSE in the United States may lead to decreased 
consumption of beef, the market has not substantiated this conclusion. 
In the first year after the December 2003 BSE discovery, beef 
consumption increased. While consumption in 2005 was above 1998 levels, 
consumer demand started to decline. This decline was likely due to a 
combination of factors, including increased supplies of poultry and a 
slowing of growth in consumers' disposable incomes (Mintert, 2006). 
There is no evidence to suggest a decline in consumption related to the 
confirmation of additional cases of BSE in the United States.
    Issue: Several commenters stated that APHIS' economic analysis does 
not consider potential demand changes regarding exports of U.S. beef 
that could result from implementation of the proposed rule. A number of 
commenters expressed concern that the rulemaking would exacerbate the 
limited access of U.S. beef to world markets and harm the ability of 
the United States to restore lost export markets. Commenters stated 
that imports of Canadian cattle and beef are currently banned by 35 
countries, including the important U.S. export markets of the Republic 
of Korea, Singapore, and Taiwan, and that APHIS should not consider 
relaxing its BSE import restrictions in light of ongoing international 
concerns regarding the safety of Canadian beef and cattle. Other 
commenters stated that the United States should allow imports only of 
classes of cattle and beef that U.S. export markets are willing to 
accept from the United States.
    Several commenters expressed concern that, should Mexico cease 
accepting imports of cattle and beef from Canada, the commingling of 
Canadian and U.S. cattle and beef products would negatively affect the 
reopening of Mexico to U.S. live breeding cattle and the present export 
of processed beef to Mexico.
    Response: The commenters raise the concern that, by allowing 
Canadian cattle born on or after March 1, 1999, to be imported into the 
United States, U.S. beef export markets will become more restrictive. 
Various countries have enacted different levels of restriction on beef 
imports from the United States and Canada. However, we expect any 
restrictions placed on beef from the United States and Canada by an 
importing country to become more uniform, as discussed below, and, 
therefore, for the rule to have little effect on U.S. beef export 
markets.
    The reason for the expected uniformity is the May 2007 OIE decision 
to classify both Canada and the United States as BSE controlled risk 
countries. By this decision, the OIE recognized the effectiveness of 
the science-based mitigations and interlocking safeguards in both 
countries. This classification is expected to help the beef industries 
in both the United States and Canada to expand their access to export 
markets.
    Issue: One commenter stated that APHIS' economic analysis does not 
truly analyze the potential ``consumer welfare'' of the rulemaking. The 
commenter stated that the closest the analysis gets to considering the 
consumer is its consideration of wholesale buyers of processing beef 
and fed beef--whom the commenter stated APHIS should identify as the 
primary beneficiary of the rule.
    Response: The principal model that we use to estimate welfare 
effects resulting from the rule does not extend beyond the wholesale 
level to retailers and end buyers of beef. We

[[Page 53358]]

acknowledge this modeling choice in our discussion of sector impacts in 
the analysis for the final rule, and note that benefits received at the 
wholesale level can be expected to be at least partly distributed 
downstream to retailers and final buyers, depending on the levels of 
competition. Nevertheless APHIS believes this modeling choice is 
consistent with standard RIA practices, as recommended by OMB Circular 
A-4, and that it adequately identifies the impact of this regulatory 
action.
    APHIS agrees, however, that some indication of the distribution of 
benefits in different product markets would be an interesting addition 
to the model. As part of the economic analysis for the final rule, we 
simulate substitution among livestock products in response to relative 
price changes using a multi-sector model. Although meant simply to be 
illustrative and subject to considerable uncertainty, included in the 
simulations is a derivation of consumer welfare changes at the retail 
level. Results of this analysis suggest that consumer surplus for 
buyers of beef at the retail level may increase by 1.0 to 1.3 percent 
compared to a 2006 baseline.
    Issue: One commenter stated that APHIS should also broaden the 
model used in the economic analysis to account for cull animal 
producers, so that welfare implications to producers of U.S. cull 
animals and processing beef could be separated from those of the 
packers. The commenter stated that APHIS' analysis includes no single 
estimate of the economic impact of the rule on cow-calf producers 
resulting from the change in value and demand for U.S. cattle.
    A number of cow-calf producers provided estimates of the potential 
economic impact of the proposed rule on their individual operations.
    Response: In our regulatory flexibility analysis for this final 
rule, we present a sector-based analysis that includes a separate 
consideration of impacts of the rule for the cow-calf and dairy sector. 
The sector analysis uses the measures of welfare change estimated for 
cull cattle/processing beef, feeder cattle, fed cattle, and fed beef, 
distributing these changes among the commodities' principal buyers and 
sellers.
    Concerning the numerous comments we received regarding economic 
impacts of the rule on individual livestock producers, we acknowledge 
that analysis does not fully identify the distribution of all of the 
possible effects on the vast array of different types of entities that 
comprise the cattle and beef industries. Because of the different 
choices made by market participants, it would be difficult, if not 
impossible, to design such an analysis. For example, some large firms 
likely also act as wholesalers and distributors, and may be 
participants in fed cattle, feeder cattle, and other markets. The 
analysis APHIS has produced does identify the direct impacts of the 
regulation on the industry; the results of our analysis are based on 
baseline quantities and prices and import projections that are well 
supported by historical trends and economic research. The models that 
we use to estimate price and welfare effects are also well-grounded in 
theory and utilize methodologies widely accepted by economists. We are 
confident that the results of the analysis appropriately depict 
expected net effects of the rule for the modeled commodities.
    Issue: Commenters noted that APHIS estimated that 46,800 Canadian 
dairy breeding animals could be imported annually into the United 
States as a result of this rulemaking. The commenters expressed concern 
that these animals would have a negative impact on the effectiveness of 
the Cooperatives Working Together (CWT) herd retirement program, which 
the commenters noted is funded by voluntary dairy producer assessments. 
(CWT is a national program, organized by dairy farmers, with the goal 
of reducing milk supply and demand imbalances and, in doing so, of 
delivering a significant return on farmers' investments through higher, 
more stable, milk prices.)
    The commenters stated that the proposed rule would have the effect 
of having U.S. dairy farmers assessed to reduce the U.S. dairy cattle 
herd, while, at the same time, cattle are being imported from Canada to 
replace those animals.
    One commenter stated that APHIS should have made the effort to 
incorporate ``expected future net returns,'' as well as impacts on milk 
prices, into an analysis of breeding cattle imports, and that the 
economic analysis should have modeled impacts on the milk market, and 
resulting impacts on producer incomes and the price of milk cows. 
Commenters expressed the opinion that APHIS failed to meet its 
obligations under Executive Order 12866 and the Regulatory Flexibility 
Act in its economic analysis by not performing the required analyses 
regarding imported dairy replacement animals.
    Response: We do not expect imports of dairy animals from Canada to 
add significantly to the U.S. national herd, but, rather, to serve as 
an additional source of replacement animals. Dairy breeding cattle 
replacements imported from Canada during 1992 to 2002 represented about 
1.1 percent of U.S. dairy heifer replacements over this period. We have 
no reason to expect the supply of Canadian heifer replacements to be 
greater than historical levels. In fact, the numbers of dairy heifer 
replacements present on all cattle operations in Canada have been in 
decline in recent years, from 512,000 on January 1, 2003, to 476,300 on 
January 1, 2007. The number of operations that specialize in raising 
heifers has also decreased. In Ontario and Quebec, there were 487 of 
these operations on January 1, 2003, and only 296 on January 1, 
2005.\17\ The currency exchange rate is also less favorable to Canadian 
exports than it was prior to 2003.
---------------------------------------------------------------------------

    \17\ Ontario and Quebec account for approximately two-thirds of 
the dairy cattle inventory in Canada. Source: Statistics Canada, as 
cited in Al Mussell, Graeme Hedley, Don Ault, and David Bullock, 
``Role and Impact of Renewed Canada--U.S. Trade in Dairy Heifers and 
Dairy Breeding Stock,'' George Morris Centre, Informa Economics, 
February 2006. http://www.informaecon.com/
---------------------------------------------------------------------------

    There is no evidence that imports of dairy cattle from Canada have 
historically had any significant effect on the U.S. cow herd, U.S. 
dairy heifer prices, or U.S. milk prices. The U.S. milk herd declined 
from about 9.7 million head in 1992 to about 9.1 million in 2002. The 
number of U.S. milk cow replacements \18\ remained essentially steady, 
fluctuating between 4 million and 4.1 million head over that same time 
period.\19\ An empirical investigation by Mussell, et al. (2006) \20\ 
concluded that imports from Canada prior to 2003 had no statistically 
significant impact on the U.S. dairy herd. Imports of dairy heifers 
from Canada were also found to have no statistically significant impact 
on U.S. heifer prices in the United States, nor on U.S. milk prices.
---------------------------------------------------------------------------

    \18\ Heifers 500 pounds and over kept for milk cow replacements. 
Source: Agricultural Statistics, National Agricultural Statistics 
Service, USDA.
    \19\ In table 17 of the preliminary Regulatory Impact Analysis 
that accompanied our January 2007 proposed rule (Docket No. APHIS 
2006-0041), under column ``Average Annual U.S. Heifer Replacements'' 
the numbers for Beef and Dairy were transposed.
    \20\ Mussell, et al. (February 2006).
---------------------------------------------------------------------------

    As noted by commenters, a producer dairy herd retirement initiative 
called CWT is currently underway.\21\ The number of imported dairy 
breeding cattle projected in our economic analysis for the proposed 
rule was based on historical import levels prior to formation of CWT. 
Imports of dairy heifers are driven by the demand for replacement 
animals, relative prices, and the exchange rate. If dairy farmers are 
dedicated to reducing the national

[[Page 53359]]

dairy herd, they may purchase fewer replacement animals and the import 
projections may be overstated. However, if a replacement dairy heifer 
from Canada can be purchased at a lower price than a domestic one, then 
it is to the producer's (and industry's) advantage for the Canadian 
replacement to be purchased and a domestically raised animal to be 
retired. Therefore, APHIS disagrees with the commenters' claims that 
dairy producers will somehow be worse off with this rulemaking. As a 
lower priced replacement heifer would represent a lower priced input 
into the production of dairy products, standard economic theory 
indicates that producers and consumers will be better off.
---------------------------------------------------------------------------

    \21\ http://www.cwt.coop
---------------------------------------------------------------------------

    Issue: One commenter stated that APHIS' economic analysis indicates 
that imports of dairy cattle from Canada would be expected to represent 
``only'' 1.1 percent of the annual U.S. dairy heifer crop. The 
commenter stated that, although APHIS labels this percentage as small, 
a short-term change in the milking herd of 1 percent can change milk 
prices by 10 percent or more.
    Response: We agree that a 1 percent increase in the national dairy 
herd (and a corresponding increase in milk production) may result in a 
decline in milk prices. However, as we discuss above, imports of dairy 
animals from Canada that occur should serve as an additional source of 
replacement animals, rather than adding entirely to the national 
milking herd. First, we would reiterate that imports are voluntary; we 
believe any projected imports of dairy heifers would be undertaken 
because the cost saving associated with the import would be greater 
than any decrease in revenue due to relative price declines resulting 
from higher production and lower prices. We further note that we 
believe the comment overestimated the expected price declines due to 
this regulatory change. The projected number of imported dairy cattle 
is equivalent to 1 percent of the dairy heifer crop and not 1 percent 
of the entire milking herd, which is more than twice the size of the 
annual dairy heifer crop. Projected imports of dairy heifer 
replacements and other breeding cattle represent approximately 0.45 
percent of the milking herd.
    In 2006, the farm-milk supply produced from 9.1 million dairy cows 
was 181.8 billion pounds of milk (19,951 pounds per cow) at an all-milk 
price of $12.90 per cwt, which is a weighted average of the fluid grade 
milk price of $12.92 per cwt and the manufacturing grade milk price of 
$12.21 per cwt. An increase in the size of the milking herd would 
increase milk production.
    If all 47,800 \22\ dairy heifers projected to be imported from 
Canada were to constitute an addition to the U.S. milking herd, they 
would represent a 0.5 percent increase over the 2006 U.S. herd size. 
This increase would correspond to a change in milk production of 
approximately 0.5 percent.\23\ We would expect the short-run effects 
(more inelastic supply) of such an increase in the U.S. milking herd to 
be larger than the longer term effects (more elastic supply). Assuming 
a short-run supply elasticity of milk of 0.15 and a demand elasticity 
of -0.30,\24\ a 0.5 percent increase in milk production is estimated to 
decrease the milk price by 15 cents per cwt. This translates into a 1.2 
percent price decline. As supply becomes more elastic, the price 
decline resulting from a 0.5 percent increase in production becomes 
smaller. Assuming a longer run supply elasticity of 0.50 would lead to 
an estimated decline in price of 9 cents per cwt, or 0.7 percent.
---------------------------------------------------------------------------

    \22\ Projected annual imports 2008-2012.
    \23\ Assuming the additional heifers produce milk at the same 
average rate reported for the U.S. herd in 2006.
    \24\ Milk supply elasticities of 0.12 in year 1 and 2.46 in year 
10 are cited in Chavas, J.P., and R.M Klemme, ``Aggregate Milk 
Supply Response and Investment Behavior on U.S. Dairy Farms,'' 
American Journal of Agricultural Economics 78 (February 1986). A 
total dairy product demand elasticity of -0.31 is cited in 
Haidacher, R.C., J.R. Blaylock, and L.H. Meyers. ``Consumer Demand 
for Dairy Products, A Summary Analysis.'' USDA Economic Research 
Service, Agriculture Information Bulletin 537 (March 1988).
---------------------------------------------------------------------------

    This example of potential effects on milk prices due to changes in 
the size of the U.S. milking herd assumes that the projected imports of 
Canadian breeding cattle would be absorbed into the U.S. milking herd 
in their entirety, thereby slightly expanding the overall size of the 
U.S. milking herd. An analysis of scenario 3 as discussed in our 
economic analysis and in the summary of that analysis in this document 
(entry of Canadian cattle born on or after March 1, 1999, and 
resumption of imports of beef from Canadian cattle slaughtered at 30 
months of age or older) using the multi-sector model indicates that 
dairy producers may experience price declines of 1.3 to 1.7 percent for 
dairy cattle, due to the small number projected to be imported from 
Canada. These imports translate into an increase in U.S. milk 
production of 0.1 percent or less, and a decline in the price of milk 
and increase in consumer surplus of less than 0.1 percent.
    Issue: One commenter noted that the importation of live animals 
from Canada has enabled many U.S. plants to better utilize their 
slaughter capacity, allowing them to maximize plant efficiencies. The 
commenter stated that allowing the resumption of imports of older 
animals to the United States, as envisaged in the proposed rule, might 
enable some previously closed plants to reopen.
    Response: The resumption of cull cattle imports from Canada will 
provide increased throughput for U.S. slaughter plants, especially 
those that principally slaughter and process cull animals. While the 
cattle from Canada will enable these businesses to more fully utilize 
their available capacities, we do not anticipate the effects to be 
highly significant. Nor are we aware of plants that have closed and 
will be reopened due to reestablished cull cattle imports. Our analysis 
for scenario 3 as discussed in our economic analysis and in the summary 
of that analysis in this document (entry of Canadian cattle born on or 
after March 1, 1999, and resumption of imports of beef from Canadian 
cattle slaughtered at 30 months of age or older) indicates that the 
additional numbers of cull cattle marketed over the 5 years, 2008-2012, 
will not increase substantially. Compared to projected U.S. baseline 
slaughter numbers averaging 5.4 million head of cows and 570,000 head 
of bulls and stags over the 5-year period, imports of Canadian cows and 
bulls/stags are projected to average 89,400 head and 16,600 head over 
the same period, representing 1.7 percent and 2.9 percent of the 
baseline quantities. These percentages in fact overstate the expected 
impact of the rule in terms of cull cattle slaughter because they do 
not take into account the effect of expected price declines on domestic 
sales. Notwithstanding this cautious assessment of the extent to which 
the rule will benefit U.S. facilities, the slaughter industry is 
expected to benefit from improved operating efficiencies.
    Issue: One commenter stated that APHIS' economic analysis for the 
proposed rule did not consider the economic implications of the 
combination of the rule and Canada's implementation of its expanded 
feed ban on July 12, 2007, which bans the inclusion of SRMs in any 
animal feeds, pet foods, and fertilizers. The commenter stated that, 
under the expanded Canadian feed ban, SRMs in Canada will have little 
or no economic value. Instead, said the commenter, the materials will 
generate a disposal cost, thereby providing increased incentive for 
Canadian producers to ``send all their cattle over 30 months of age to 
the

[[Page 53360]]

U.S. for slaughter where the SRMs can continue to be used as 
ingredients in other U.S. animal feed, pet food, and fertilizer * * *. 
The result would be an even greater supply of imported Canadian cattle 
than what APHIS presently predicts and a correspondingly greater 
decline in U.S. cattle prices.''
    Response: We acknowledge that Canada's July 2007 expansion of its 
feed ban eliminates the value of SRMs for producers of cattle 
slaughtered in Canada, and we agree that the continued use of SRMs in 
the United States for rendered purposes other than as a component of 
ruminant feed will contribute to a difference in prices paid for cattle 
at slaughter in Canada and the United States. Because SRMs are defined 
more broadly for cattle 30 months of age or older than for animals 
under 30 months of age, this effect on relative prices in the two 
countries will be more notable for cull cattle. For all cattle, the 
tonsils and distal ileum are considered SRMs, whereas for cattle 30 
months of age or older, SRMs also include the brain, skull, eyes, 
trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse processes of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and dorsal root 
ganglia.
    However, even for cull cattle, the value of rendered SRMs is 
relatively minor in comparison to the total value of the slaughtered 
animal. In a 2005 analysis of economic impacts of alternative FDA 
animal feed regulations, the value of SRMs was estimated using a 4-year 
average of byproduct market prices.\25\ For cattle slaughtered at 
greater than 30 months of age, the value of SRMs used in MBM products 
was valued at $2.35 per animal, and the value of SRMs used for tallow 
was valued at $2.19 per animal. Thus, the total value of SRMs from cull 
cattle used as rendered byproducts is estimated to be less than $5 per 
animal. Given a projected 2008 nominal value of about $569 per cow, the 
income from SRMs gained by selling the animal in the United States 
rather than in Canada will represent less than 1 percent of the 
projected price of the animal at slaughter.\26\ Canada's July 2007 feed 
ban may make the U.S. market more attractive, but not appreciably.
---------------------------------------------------------------------------

    \25\ ``Economic Impacts of Alternative Changes to the FDA 
Regulation of Animal Feeds to Address the Risk of Bovine Spongiform 
Encephalopathy: Final Report.'' Submitted by Eastern Research Group, 
Inc. to the Office of Policy and Planning, Food and Drug 
Administration, July 25, 2005.
    \26\ Boning utility cow, Sioux Falls, price of $54.19 per cwt, 
multiplied by an average weight of 1,050 pounds yields an average 
value of $569 per animal. Assuming a total value per cow for 
rendered SRMs of five dollars: $5/$569 = 0.0088.
---------------------------------------------------------------------------

    Issue: One commenter stated that APHIS' analysis of the projected 
economic effects of the rule should be revised to take into account the 
handling of increased amounts of SRMs.
    Response: In the regulatory impact analysis we conducted for this 
rule, projected prices for processing beef and fed beef incorporate 
animal slaughter and meat packing costs, including costs of handling 
SRMs. Costs and returns per animal of handling SRMs are not expected to 
change for slaughtering facilities because of the rule and therefore do 
not require specific analysis. Copies of the full amended analysis may 
be viewed on the APHIS Web site (http://www.aphis.usda.gov/newsroom/hot_issues/bse/index.shtml), or be obtained by contacting the person 
listed under FOR FURTHER INFORMATION CONTACT.

Environmental Assessment for the Rulemaking

    Consistent with the National Environmental Policy Act of 1969 
(NEPA), as amended (42 U.S.C. 4321 et seq.), regulations of the Council 
on Environmental Quality (CEQ) for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508), and APHIS' NEPA 
implementing procedures (7 CFR part 372), we prepared an environmental 
assessment (EA) regarding the potential impact on the quality of the 
human environment due to the importation of live bovines and products 
derived from bovines under the conditions specified in our proposed 
rule. We made the EA available to the public and accepted public 
comment on its provisions. We discuss below the issues raised by 
commenters who addressed the EA.
    Issue: One commenter stated that the EA that APHIS conducted for 
the proposed rule did not adequately discuss the impact of air 
emissions from additional truck round-trips entering the United States 
that would result from importation of cattle 30 months of age and older 
from Canada. The commenter stated that USDA apparently did not consider 
the fact that these emissions would be concentrated in relatively small 
parts of the country. Further, said the commenter, the EA's discussion 
of air pollutants and mitigation measures is limited to those 
pollutants regulated under the Clean Air Act and does not recognize 
what the commenter described as substantial emissions of greenhouse 
gases that could result from the additional truck trips.
    Response: Our EA estimated that the number of additional cattle 
that would be available for importation into the United States as a 
result of this rule would result in a 0.05-0.16 percent increase in 
truck transports, compared to the annual truck transport baseline, 
discussed below. However, more recent data from ERS indicate that the 
number of additional cattle that would be available and eligible for 
import from Canada as a result of this rulemaking initially will be 
less than the number we used in the calculations for our October 2006 
EA. Consequently, the estimated number of truck transports initially 
will also be less, as will the emissions generated by such transports.
    In the finding of no significant impact (FONSI) (APHIS 2005a) that 
APHIS made in conjunction with our January 2005 final rule, we 
discussed truck transports for cattle under 30 months of age. Prior to 
implementation of that final rule, the projected number of imports of 
cattle under 30 months of age would have caused the resumption of about 
35,000 truck transports. The FONSI for our January 2005 final rule 
determined that the result of environmental impacts from resuming 
35,000 trucks transports would be de minimus. Afterward, based on a 
decrease in the projected number of available imported animals under 30 
months of age, the estimated number of truck transports projected to be 
resumed was adjusted downward to range between 19,460 to 22,140 
annually.
    As discussed in the EA for this final rule, for cattle born on or 
after March 1, 1999, cattle import numbers are projected to range 
between 130,000 to 446,000 over a 20-year period after implementation 
of this rule. The number of associated truck transports that would 
resume for this rule would range from 2,600 to 8,920. When added to the 
truck transports resumed as a result of our January 2005 final rule, 
the total number of projected resumed truck transports is still within 
the amount described in the FONSI for our January 2005 final rule as de 
minimus. Additionally, that projected number is within the number of 
truck transports for cattle trade that occurred between Canada and the 
United States before such trade was temporarily halted in May 2003.
    As we stated in our EA, the transport of cattle could occur through 
any of 20 U.S.-Canadian border ports specifically equipped to handle 
cattle. These ports are not confined to one region of the United 
States, but stretch across nine northern border States from Washington 
to Vermont. Market patterns and geographic issues can cause 
fluctuations in the availability and importation of cattle. 
Availability of cattle for

[[Page 53361]]

importation also can vary depending upon the time of year and 
geographic location. For example, most feeder cattle are imported 
through certain western ports from areas with the highest cattle 
population in Canada, and more feeder cattle may become available in 
the fall when ranchers wean calves and sell them. Cull cattle for 
immediate slaughter historically have come through different ports than 
feeder cattle, including some eastern ports. Emissions from trucks 
importing cattle from Canada could affect any of the 20 locations at 
the U.S.-Canadian border and any location between transport origination 
and destination.
    In determining if the impacts from truck transport emissions from 
carrying additional cattle as a result of this rule could result in a 
significant impact on the environment, a baseline of the annual overall 
truck transports was used. In this case, the baseline used for 
comparison was for all incoming trucks from Canada to the United States 
through 20 approved ports of entry where cattle can transit to 
determine whether the increase in the numbers of imported cattle would 
cause a significant increase in air emissions. The comparison of the 
baseline (the average number of heavy-duty truck crossings annually 
between the U.S.-Canadian border) to the number of truck transports 
estimated for cattle 30 months of age and older that would be available 
to be imported from Canada annually shows that the increase in the 
number of truck transports would not be significant.
    To a great extent, projecting the specific air emissions that would 
result from implementation of this rule would be speculative. Emissions 
vary according to many different factors, including type of truck 
engine, the year the engine was manufactured, fuel properties, the type 
of hauler and weight of the load, the grade of the highways on the 
transport routes, the distance traveled, speed and acceleration, and 
the amount of wait time at the border ports. Due to the comparatively 
small amount of truck transports (ranging from 2,600 to 8,920) that are 
projected to result from this rule in relation to the baseline, 
speculating on the specific air emissions that would result from this 
rule would not result in information indicating that the indirect 
impacts, unassociated with the scope of this rule, would contribute to 
significant adverse impacts on the environment from resuming imports 
from Canada of cattle over 30 months of age born on or after March 1, 
1999.
    The method of transporting cattle and the type of vehicle to be 
used are not mandated by APHIS regulations. Emissions from the 
transport of cattle, or of any commodity moved by modern transport 
methods, are unavoidable. However, measures to reduce the impacts from 
vehicle emissions are enforced by environmental statutes, such as the 
Clean Air Act, at both the State and Federal levels and have been 
reported to be effective in regulating and decreasing vehicle 
emissions. Mitigations for vehicle emissions are under the jurisdiction 
of the U.S. Environmental Protection Agency and State government 
agencies and are outside of the mission of APHIS.
    The commenter is correct that the EA did not discuss the 
contribution of greenhouse gases from the transport trucks that would 
be used to import cattle and did not discuss mitigation measures for 
greenhouse gases. We note that draft guidance provided to Federal 
agencies from the Council on Environmental Quality with regard to 
consideration of global climatic change in environmental documents 
calls for consideration, in the context of NEPA, of how major Federal 
actions could influence the emissions and sinks of greenhouse gases and 
how climate change could potentially influence such actions.\27\ We 
interpret that this guidance does not apply to this rulemaking because 
it is not a major Federal action that could influence the emissions and 
sinks of greenhouse gases .\28\
---------------------------------------------------------------------------

    \27\ Memorandum to All Federal NEPA Liaisons, dated October 8, 
1997, from Dinah Bear, General Counsel, Executive Office of the 
President, Council on Environmental Quality, with attached draft 
memorandum from Kathleen A. McGinty, Chairman, on Guidance Regarding 
Consideration of Global Climatic Change in Environmental Documents 
Prepared Pursuant to the National Environmental Policy Act.
    \28\ A sink is, simply speaking, the converse of a source. 
Instead of releasing carbon into the atmosphere as is done when 
fossil fuels or wood are burned, sinks absorb carbon and lock it in. 
The most obvious examples are trees and other plants.
---------------------------------------------------------------------------

    Issue: One commenter stated that APHIS' EA did not assess the 
environmental impact of holding and feeding in the United States each 
year hundreds of thousands of Canadian cattle 30 months of age or 
older.
    Response: Approximately 34 million head of cattle are slaughtered 
in the United States each year. Approximately 0.13 to 0.45 million 
additional head of cattle would be available annually and eligible for 
importation from Canada under this rulemaking. The majority of cattle 
that we anticipate being imported from Canada and held in feedlots will 
be cattle under 30 months of age that are already allowed importation 
from Canada under our January 2005 final rule. The majority of 
additional cattle that we expect to be imported as a result of this 
rulemaking would consist of cows, bulls, and stags imported directly 
for slaughter that would remain in a holding facility of the slaughter 
facilities for approximately 1 to 2 days before slaughter. A small 
percentage of the remainder of the cattle that we expect to be imported 
as a result of this rulemaking would consist of breeding cattle (for 
example, dairy or beef cows and heifers and bulls) that would be 
integrated into a cattle herd for an indefinite period of time. Thus, 
for purposes of the EA, the cattle that would be imported would not be 
held in feedlots for a long duration and would not contribute to an 
increase to the baseline of the number of cattle produced in the United 
States and held and fed in feedlots each year.
    Pollutant discharges and emissions from holding cattle in feedlots 
are unavoidable; however, measures to reduce the impacts from feedlot 
discharges and emissions are enforced by environmental statutes, such 
as the Clean Water Act and the Clean Air Act, at both the State and 
Federal levels. Requirements for mitigating pollutant discharges and 
emissions, under the jurisdiction of Federal and State government 
agencies, are intended to protect the human environment of the United 
States.
    Issue: One commenter expressed the opinion that our EA was 
inadequate because, according to the commenter, it failed to explain 
why the potential for widespread distribution of infectious BSE prion 
proteins is not a significant environmental impact. The commenter 
expressed concern that blood and SRMs that will be collected when 
cattle of Canadian origin that are over 30 months of age are 
slaughtered can be used as fertilizer and be spread on the ground (and 
ingested as well as running off into streams) on farms throughout the 
United States. The commenter stated further that the EA did not assess 
the environmental impact of distributing infectious BSE prion proteins 
in animal feed that will be used (and spilled, disposed of, and 
excreted) on farms across the United States. The commenter stated that 
OIE guidelines prohibit trade in SRMs for use in fertilizer, as well as 
trade in fertilizer contaminated with SRMs.
    Response: The commenter did not specify, and it is not clear to us, 
in what manner the commenter anticipates prions being widely 
distributed through animal feed and fertilizer and having a significant 
impact on the quality of the human environment. Scientists believe that 
the primary route of BSE

[[Page 53362]]

transmission in cattle requires that an animal ingest feed that has 
been contaminated with a sufficient amount of tissue from an infected 
animal. In humans, vCJD, a chronic and fatal neurodegenerative disease 
of humans, has been linked via scientific and epidemiological studies 
to exposure to the BSE agent, most likely through consumption of cattle 
products contaminated with the BSE agent. Therefore, our assumption is 
that the commenter's primary concern regarding the potential impact of 
feed and fertilizer on the environment is the potential consumption of 
BSE-contaminated feed or fertilizer by ruminants or humans. We also 
consider it possible that the commenter is concerned about the 
potential for the BSE agent to be consumed by animals other than 
ruminants, excreted by those animals, and subsequently consumed by 
ruminants or humans.
    The commenter stated that APHIS inadequately assessed the potential 
environmental impact of contaminated feed and fertilizer. We disagree 
with the commenter. Our EA evaluated the potential impact of the 
proposed rule on the physical environment, public health, and 
endangered species, as well as cumulative impacts of any of the above. 
The EA referenced and discussed the conclusions of the risk assessment 
we conducted for this rulemaking, in which we assessed the likelihood 
that U.S. cattle would be exposed to the BSE agent as a result of this 
rule. Our risk assessment examined the likelihood of exposure of 
ruminants to BSE via feed.
    Our evaluation of risk included an understanding that SRMs from 
live cattle imported under the conditions of the proposed rule would 
enter the U.S. rendering system, in the same fashion that SRMs from 
cattle of U.S. origin are generally disposed of. The protein products 
from the rendering system could then be incorporated into either animal 
feed or fertilizer. We assumed in the risk assessment that the vast 
majority of rendered protein products are sold for use in animal feed. 
The commenter makes this assumption as well, stating that ``* * * SRMs 
can be used as a protein source for animal feed other than ruminant 
feed, and it is reasonable to assume that they will be, given the 
favorable economics of this use as compared to SRM disposal.''
    The quantitative exposure model used in the risk assessment 
specifically simulated potential exposures through feed--either through 
ruminant feed that was mislabeled or cross-contaminated, through other 
animal feed that was misfed to ruminants, or directly through poultry 
litter that could contain spilled feed and be fed back to cattle. These 
pathways are the most direct exposure of cattle that could occur.
    We disagree with the commenter's assertion that APHIS did not 
consider ``spilled, disposed of, or excreted'' animal feed as a 
potential pathway of BSE transmission. The poultry litter pathway 
modeled in the quantitative exposure model specifically addresses 
spilled and even undigested excreted feed, with very conservative 
assumptions about potential infectivity retained in such feed. The 
issue of feed being ``disposed of'' is addressed through the misfeeding 
component of the model, which incorporates situations where non-
ruminant feed is fed directly to cattle. These situations would include 
those where a producer either mistakenly or intentionally feeds non-
ruminant feed to ruminants. Mislabeling and misfeeding components would 
include situations where non-ruminant feed is sold for salvage value. 
We are not aware of similar situations where litter or waste from other 
species--for example, swine litter--that contains quantities of either 
spilled or undigested feed is routinely used for cattle feed. Further, 
there is no evidence to date of environmental contamination (e.g., via 
fecal or other bodily excretions) being a route of transmission of BSE. 
Therefore, we do not consider there to be potentially significant 
pathways for exposure of susceptible animals to BSE-contaminated feed 
that were not considered in the risk assessment.
    With regard to potential exposure of humans to the BSE agent, there 
is no evidence, anecdotal or otherwise, to suggest any likelihood of 
BSE-contaminated animal feed, spilled or excreted, being consumed by 
humans, and we consider the risk of such exposure to be negligible.
    The commenter also stated that the EA should have examined the 
potential impact on the environment of BSE-contaminated fertilizer. As 
noted above, although rendered protein can be a component of 
fertilizer, such usage is not common because most rendered proteins are 
sold for use in feed. Any consideration of animal health exposure from 
fertilizer would be an evaluation of the risk of cattle exposure to BSE 
through oral consumption of fertilizer that contains rendered protein. 
Our quantitative exposure model evaluates the potential oral exposure 
of cattle to feed containing such rendered protein. It does not 
specifically model potential exposure through fertilizer. However, it 
assumes that all rendered ruminant protein products are sold for feed 
use. Therefore, any of the infectivity contained in rendered ruminant 
protein is already simulated through the potential for direct feed 
exposure. This is a more direct pathway than any potential consumption 
of a component of a fertilizer product, some undefined time after it 
was spread on a pasture. Therefore, any potential exposure through 
fertilizer would be assumed to be far less than the exposure the model 
already takes into account through the consumption of feed.
    It appears that the commenter is suggesting that raw, untreated 
SRMs might be spread directly on land as fertilizer. Raw or untreated 
tissues are not generally used as fertilizer, and, in fact, are often 
prohibited from being spread on land through environmental regulations 
on carcass/offal disposal and solid waste disposal. Therefore, this 
risk pathway was not considered in our risk assessment.
    With regard to the likelihood of exposure of humans to the BSE 
agent through fertilizer, we are assuming the commenter is not 
referring to potential consumption by humans of fertilizer, and is 
referring instead to some other method of BSE transmission to humans 
through fertilizer. As noted above, there is no evidence to date of 
environmental contamination being a route of transmission of BSE.
    Regarding the commenter's statement that OIE guidelines recommend 
that trade not be carried out in SRMs for use in fertilizer, as well as 
trade in fertilizer contaminated with SRMs, the primary purpose of such 
guidelines is to reduce the possibility of the consumption by cattle of 
such product due to mislabeling or misdirection of shipments--e.g., 
through having SRM-derived protein for fertilizer mistakenly sent to a 
feed mill.

Other Issues

    A number of commenters raised other issues that did not address the 
provisions of the proposed rule.

Requests Regarding the Importation of Additional Commodities

    We received comments that requested that bovine commodities not 
specifically addressed in our proposed rule be made eligible for 
importation into the United States.
    Issue: Several commenters requested that U.S. regulations with 
regard to BSE allow the importation of the same commodities that Canada 
considers eligible for importation from the United States.
    Response: Although in most cases, Canadian and U.S. import 
restrictions regarding BSE are comparable, we do not consider it 
practical or advisable to

[[Page 53363]]

attempt to mirror the regulations of another country, given differences 
in regulatory approach, structure, and authority.
    Issue: Commenters requested that the current regulations be amended 
to allow the importation from BSE minimal-risk regions of rendered feed 
products--including bovine-derived meat-and-bone meal and blood meal--
that are manufactured in compliance with U.S. regulations if the 
products can be determined to meet the health protection objectives of 
the recommended standards of the OIE.
    Response: The recommended standards of the OIE clearly state that 
ruminant-derived rendered protein should not be traded from either 
controlled risk or undetermined risk countries.
    For the reasons discussed above, we are making no changes based on 
these comments.

APHIS's Use of the Term ``Minimal-Risk Region''

    Issue: Several commenters requested that APHIS discontinue 
classifying and referring to countries as ``BSE minimal-risk regions.'' 
The commenters stated that APHIS's definition of ``minimal-risk 
regions'' does not follow the scientific terminology of the OIE, which 
classifies countries with regard to BSE risk as ``negligible,'' 
``controlled,'' or ``undetermined.'' One commenter stated that APHIS's 
classification of BSE minimal-risk regions may create confusion and be 
seen as not accepting the OIE categorization criteria.
    Response: At the time APHIS published its January 2005 final rule 
to recognize a category of BSE minimal-risk regions, the OIE guidelines 
regarding BSE provided for five possible BSE classifications for 
regions. For each classification, the guidelines recommended different 
export conditions for live animals and products, based on the risk 
presented by the region. Although APHIS did not incorporate the text of 
OIE's BSE guidelines into its January 2005 rule, the agency based its 
standards regarding BSE minimal-risk regions on these guidelines. 
Although we are making no changes based on the comments, it is APHIS's 
intent to develop rulemaking that would more closely employ terminology 
used in the current OIE standards.

BSE Surveillance in the United States

    Issue: Several commenters expressed general concern with the 
effectiveness of the current BSE testing program in the United States. 
One commenter stated that a report issued by the U.S. Office of the 
Inspector General (OIG) called into question USDA's ability to 
adequately detect BSE, even before the most recent reduction in the 
U.S. surveillance program. The commenter stated that an OIG report 
pointed to the voluntary nature of the surveillance program and the 
program's sampling protocols as indicators that the surveillance 
program may not have been providing an accurate picture of BSE 
prevalence in the United States. The report also noted that the 
surveillance program, which focused on high-risk cows, did not account 
for emerging evidence that BSE has been detected in seemingly healthy 
animals.
    Response: We assume the commenters are referring to an OIG audit 
report issued in August 2004. This audit was conducted prior to the 
implementation of the enhanced surveillance program and, therefore, was 
limited in the conclusions that could be made about the performance of 
that effort. The report stated the following: ``Our review was limited 
because implementation plans have not been finalized and APHIS has not 
yet been able to address some of the questions we have raised.'' 
Nevertheless, APHIS responded to the recommendations provided by OIG 
and addressed the issues raised. A second audit report was issued in 
January 2006, covering both the surveillance program and FSIS' controls 
on SRM requirements and advanced meat recovery products. This report 
included a recommendation, among others, for transparency in the 
analysis and conclusions derived from the data obtained during the 
surveillance efforts. APHIS has subsequently completed and released a 
detailed summary of the data obtained during the enhanced surveillance 
effort, and an estimate of the prevalence of BSE in the United States 
adult cattle population. This analysis concluded that the prevalence of 
the disease in this country is extremely low, less than 1 case per 
million adult cattle. Two models were used to estimate the prevalence, 
and the most likely values calculated by these models for the estimated 
number of cases were 4 or 7 infected animals out of 42 million adult 
cattle. APHIS' analysis was submitted to the scrutiny of a peer review 
process, and the expert panel agreed with the appropriateness of APHIS' 
assumptions and the factors it considered, as well as with the estimate 
of BSE prevalence.

Country-of-Origin Labeling

    A number of commenters recommended that APHIS postpone 
implementation of this rule until mandatory country-of-origin labeling, 
as prescribed by the 2002 Farm Bill, is in place in this country.
    Response: On May 13, 2002, President Bush signed into law the Farm 
Security and Rural Investment Act of 2002, more commonly known as the 
2002 Farm Bill. One of its many initiatives requires country of origin 
labeling (COOL) for beef, lamb, pork, fish, perishable agricultural 
commodities and peanuts. On January 27, 2004, President Bush signed 
Public Law 108-199 which delays the implementation of mandatory COOL 
for all covered commodities except wild and farm-raised fish and 
shellfish until September 30, 2006. On November 10, 2005, President 
Bush signed Public Law 109-97, which delays the implementation for all 
covered commodities except wild and farm-raised and shellfish until 
September 30, 2008. As described in the legislation, program 
implementation is the responsibility of USDA's Agricultural Marketing 
Service.
    The COOL program, when fully implemented, will address the concerns 
raised by commenters with regard to APHIS' proposed rule. APHIS does 
not consider it necessary to delay implementation of this rule until 
those labeling provisions are implemented. In its October 30, 2004 
proposal, AMS noted, in discussing Section 10816 of Public Law 107-171 
(7 U.S.C. 1638-1638d) regarding COOL that the ``intent of the law is to 
provide consumers with additional information on which to base their 
purchasing decisions. It is not a food safety or animal health measure. 
COOL is a retail labeling program and as such does not address food 
safety or animal health concerns.''

Comments on Other Issues Outside the Scope of This Rulemaking

    A number of other comments also addressed topics outside the scope 
of the proposed rule. These comments included the following issues: 
Concern that the examination and euthanization of cattle be carried out 
in a humane fashion; a request to extend the U.S. ban on the slaughter 
of nonambulatory cattle to include all livestock species; 
recommendations regarding the type of penalties USDA should impose for 
noncompliance with the regulations; comparison of U.S. and Canadian 
regulations regarding the rendering of cattle slaughtered on-farm; the 
importation of composted bovine manure from BSE minimal-risk regions; a 
request to allow the importation of breeding stock and embryos of small 
ruminants, such as sheep; a request that the USDA allow the importation 
from BSE minimal-risk regions of up to 5 kilograms of bovine meat and 
meat

[[Page 53364]]

products for personal use without certification; and concerns regarding 
diseases other than BSE.
    For the reasons discussed above, we are making no changes to the 
proposed rule based on these comments.

Final Report From Peer Review of APHIS' Risk Assessment and Responses 
to Peer Reviewer Questions and Recommendations

    As discussed above under the heading ``Peer Review of APHIS' Risk 
Assessment,'' we requested an external, formal, and independent peer 
review of our risk assessment by recognized experts in the field. The 
objective of the peer review was to determine whether the risk 
assessment was scientifically sound, transparent, and consistent with 
international standards (e.g., those developed by OIE); the application 
of external assessments or models was appropriate; and the assumptions 
were justified, supported and reasonable. In summary, the reviewers 
found that the methods used in the risk assessment were scientifically 
rigorous in terms of using existing literature and models appropriately 
and making sound assumptions and that the risk assessment itself 
adhered to international risk assessment standards. The reviewers also 
agreed with the conclusion that the likelihood of establishment of BSE 
in the U.S. cattle population is negligible. They also asked a variety 
of questions and suggested minor refinements. APHIS' full response to 
the comments and recommendation of the peer reviewers may be viewed on 
the APHIS Web site (http://www.aphis.usda.gov/newsroom/hot_issues/bse/index.shtml ).
    Some of the questions raised by peer reviewers were also posed in 
public comments on our proposed rule and are addressed above in our 
responses to public comments. In addition, we set forth here certain 
other questions and recommendations from peer reviewers that we 
consider representative of the content-related questions and 
recommendations of the report, and our response to those questions and 
recommendations.
    Issue: A reviewer suggested that we more explicitly list the 
specific risks to be addressed in the assessment.
    Response: The risk of BSE evaluated in the assessment is the 
expected impact of importing from Canada live animals, blood and blood 
products, and small intestines excluding distal ileum. These impacts 
include the potential for establishment of BSE in the United States and 
the projected consequences of any additional cases that might occur 
even without establishment. The risk was evaluated qualitatively for 
all commodities and also quantitatively for additional live animal 
import scenarios. For the latter, the likelihood of establishment is 
measured by the disease reproductive rate (R0). We also 
simulated the total number of animals in the United States that might 
become infected with BSE as a result of the importation of live bovines 
from Canada over the 20 years. Of the infected animals, those that we 
assumed might have economic impacts were only the animals expected to 
live long enough to display clinical signs, as these are the most 
likely to be detectable with current testing methods. We have added 
this clarification to the Introduction of the revised risk assessment.
    Issue: A reviewer suggested that the analysis needs to acknowledge 
the exogenous sources of BSE into Canada. As phrased by the reviewer:

    For the assumption that BSE prevalence in Canada would decrease 
over the next 20 years until the disease is eradicated, the authors 
relied on compelling evidence from the U.K. experience with the 
ruminant feed ban and the resulting dramatic decrease in BSE 
prevalence in cattle. However, this did not address any issues 
associated with exogenous sources of BSE into Canada (imports from 
other BSE-affected countries). The Canadian prevalence model used 
for this analysis appears to assume no new exogenous sources of BSE. 
The dilution of risk due to current practices that reduce the 
likelihood of spread of prions through the Canadian cattle herd make 
this risk minimal at best, but it should be addressed for the sake 
of completeness.

    Response: The prevalence estimation models use BSE surveillance 
data (test results from dead or slaughtered cattle) as inputs and 
therefore cannot differentiate whether the source of infectivity is 
endogenous (recycled) or exogenous (introduced). Also, because they are 
based on actual surveillance data, they cannot attempt to predict any 
changes in Canadian BSE prevalence over the next 20 years. The 
qualitative prediction of a drop in prevalence is based on the 
experience in the United Kingdom and does not assume that no additional 
infectivity can be introduced. In addition, the results of the U.S. 
Harvard model presented in our risk assessment illustrate that, despite 
the recurrent release of ``exogenous infectivity'' (in this case, from 
Canada), the reproductive constant, R0, remains well below 
one, indicating that the mitigations in place (particularly the 
ruminant feed ban) are effective in driving disease prevalence 
downward. Since the feed ban in Canada is very similar to that in the 
United States, we expect that any additional infectivity that may 
potentially enter Canada would fail to alter our predictions of a 
decrease in prevalence over time. For these reasons, we do not 
explicitly address the source of BSE infectivity in Canada as either 
endogenous or exogenous.
    Issue: A reviewer suggested that we address the amount of 
uncertainty that is associated with the conclusion that the likelihood 
of releasing BSE into the United States from Canada via importation of 
live bovines is extremely low. He suggested that we report and use the 
95th confidence levels throughout the assessment.
    Response: Uncertainty between prevalence estimation models (BBC or 
BSurvE) is greater than the statistical uncertainty within prevalence 
estimation models (represented by confidence levels for a given model). 
Therefore, uncertainty about prevalence is addressed by considering the 
two expected (average) prevalence estimates obtained with different 
models. The reviewer also commented that the expectation that 
prevalence remains stable at the lower level estimated by the BBC model 
over the next 20 years is ``a very pessimistic assumption.'' Similarly, 
another reviewer stated that it is ``very reasonable'' to assume that 
BSE prevalence in Canada will decrease over the next 20 years until the 
disease is eradicated . If these assertions are correct, then assuming 
that prevalence remains stable at the 95 percent (or 99 percent) 
confidence level estimated by the BSurvE model over the next 20 years 
would simply result in a more extremely pessimistic assumption. A 
reviewer commented: ``It should'be pointed out that the other 
pessimistic assumptions in the Exposure Assessment model (for example 
no decrease in BSE prevalence over the next 20 years) would likely 
override any underestimate of the present BSE prevalence due to using 
the mean BBC prevalence estimate.'' For the reasons noted above, we 
have elected not to rerun the exposure model using the 95 (or 99) 
percent confidence level.
    Issue: A reviewer commented that ``[o]ne argument that might be 
made is that introduction will not lead to an establishment of a cycle 
of infection but may extend the temporal occurrence of the number of 
cases of BSE in the U.S. Are there any adverse economic effect[s] 
associated with this outcome? One possibility is that testing levels 
might need to be maintained for a longer time than if there were no 
more introduced and detected BSE cases. Market access and prices for 
beef and beef products might also be adversely affected.''
    Response: The APHIS risk assessment did not consider endogenous 
levels of

[[Page 53365]]

BSE in the U.S. cattle herd; however, continuous exogenous inputs of 
BSE infectivity from Canada (as is assumed in the less likely 
quantitative scenarios of the risk assessment) or any other source 
would extend the time to eradication of the disease in the United 
States. Although the incremental duration of the extended time to 
eradication is unknown, we expect that it would have little or no 
practical effect on the potential economic impacts of BSE in the United 
States. We note that the exposure model, which incorporates several 
risk-inflating assumptions, estimates that, over the 20 years of the 
analysis, there will be less than one clinical case of BSE in the 
United States as a result of the cattle imported from Canada. Given 
that the United States has already detected three BSE cases (two in 
native cattle), we do not expect any incremental impact (from a 
lengthened period of testing or from additional market impacts) of this 
very small number of potential additional cases. This point is 
described in detail in the consequence section of our risk assessment.
    Issue: One reviewer requested greater attention to uncertainty 
throughout the document. The reviewer stated, in reference to our risk 
assessment, that ``uncertainty is consistently underplayed if not 
ignored'' and ``it would perhaps be useful to actually list the sources 
of uncertainty in each of the sections. Another commenter suggested 
that we list all the model inputs considered to be variable.
    Response: We disagree with the reviewers. Though not always 
addressed as distinct lists, uncertainty and varibiality are 
incorporated throughout the risk assessment. The models used in the 
risk assessment are complex with a large number of inputs, which, as 
for most models, may be somewhat uncertain and/or variable. However, 
preparing a comprehensive list of uncertain and/or variable risk 
assessment model inputs is not necessary. In our judgment, the inputs 
are better discussed in the context of how they are used in the model.
    All of the BSE prevalence estimation model inputs represent best 
available estimates of either a variability distribution (e.g., BSE 
incubation period, cattle age structure) or a parameter value (e.g., 
number of adult animals in the herd, age of a BSE tested animal). 
Consequently, the calculated confidence intervals represent statistical 
uncertainty about current BSE prevalence related to random sampling 
error. The major source of uncertainty regarding BSE prevalence in the 
current standing cattle population was considered to be the effect of 
the Canadian feed ban. This uncertainty was addressed by considering 
two BSE prevalence estimation models: The BBC model, which incorporates 
an estimate of the effect of the feed ban based on evidence from the 
United Kingdom, and the BSurvE Prevalence B model, which makes no 
assumptions about the effect of the feed ban. Variability also entered 
into the prevalence calculation in that the BBC prevalence model 
assumes that birth year cohort prevalence declined during the first 
five years after Canada introduced a feed ban in 1997. Thereafter, both 
the BBC and BSurvE models were used to obtain the expected proportion 
of BSE infected animals, which is assumed to remain constant over time 
in the quantitative risk analysis.
    Another component of the release assessment, for which uncertainty 
has not been addressed, is the projection of imports. These projections 
were prepared by USDA ERS and were based on USDA baseline projections 
and a broad array of expert opinion. Because they are projections, they 
are uncertain. This uncertainty has been reduced somewhat by 
incorporating more recent data into the 2007 import projections, 
prepared for the final rule. Based on these updates, we expect lower 
numbers of older animals to be imported in the early years of the 
rule's implementation. The total imports over the entire 20 years of 
the analysis are only slightly (125,000 animals) higher than the 
original and so do not confer significant additional magnitude of 
release (125,000*0.68*10-6=0.085 cases; 
125,000*3.9*10-6=0.49 cases). Therefore, although the import 
projections are somewhat uncertain, reduction of this uncertainty has 
not significantly changed our release estimates or conclusions.
    The projections used in the original analysis incorporated temporal 
variability across years due to the cattle cycle. The variability 
considered did not include possible but less likely extremes (shocks), 
such as a temporary spike in slaughter rates due to severe weather.
    The parameters for the exposure model have been described in 
earlier documents (Cohen, et al., 2003). These documents explicitly 
examined the effects of uncertainty in key parameters in their 
respective sensitivity analyses. The version of the Harvard model 
performed for this rule included a sensitivity analysis to examine the 
uncertainty of several parameters--some of which were included in 
earlier models, and some of which were new parameters (e.g., the amount 
of chicken litter incorporated into ruminant feed) and the Canadian BSE 
prevalence estimate) (APHIS 2007a). Of the uncertain parameters 
examined, Canadian BSE prevalence over the next 20 years was the most 
significant source of uncertainty for the model. This uncertainty 
contains two components: The estimate of prevalence in Canada's current 
standing cattle population, and how prevalence of BSE in Canada will 
change over time. This latter component was not treated quantitatively, 
and its uncertainty was therefore not explicitly analyzed in the 
sensitivity analysis. Variability in this parameter was addressed, 
however. Assuming constant prevalence over the next 20 years, the 
simulated number of BSE infected cattle imported each year still 
varies, because it is a combination of the predicted import volume 
(which varies as described above), and the sampling variation (using a 
Poisson distribution) about the expected prevalence value. This source 
of variation has already been described in the risk assessment.
    In conclusion, rather than perform a comprehensive uncertainty 
analysis in which all model inputs are treated as statistical 
distributions, we identified and evaluated the potential contributions 
to variability and uncertainty that we deemed most relevant to our 
analysis. Given that the uncertainty about the key inputs to the risk 
assessment models has been considered, we agree with the reviewers that 
further uncertainty analysis will not affect the conclusions of the 
risk assessment.

Adoption of this Final Rule

    Therefore, for the reasons given in the proposed rule and in this 
final rule, we are adopting the proposed rule as a final rule, without 
change.

Applicability of the March 1, 1999, Date to Imports of Beef

    Issue: Several commenters stated that it was not clear from the 
proposed rule whether the March 1, 1999, date of birth requirement for 
live bovines imported into the United States from Canada would apply as 
well to frozen beef products derived from cattle slaughtered in Canada 
and shipped to the United States. If the same effective date does not 
apply, stated the commenter, USDA should specify what date would be 
used for imported frozen beef products. One commenter stated that, in 
addition to prohibiting the importation of beef from cows born before 
March 1, 1999, the regulations should limit the importation of beef 
from BSE minimal-risk regions to that derived from cows slaughtered no 
earlier than March 1, 1999.

[[Page 53366]]

    Response: We do not consider it necessary to address the 
importation of beef from BSE minimal-risk regions in this rulemaking, 
because the importation conditions for meat, meat byproducts, and meat 
food products derived from bovines were addressed in the rulemaking for 
our January 2005 final rule (in which we added the category of BSE 
minimal-risk regions to the regulations and specified which commodities 
may be imported from such regions). The risk analysis we conducted for 
that rulemaking indicated a low BSE risk from such commodities derived 
from bovines of any age if certain conditions are met. In that 
rulemaking, we discussed regulatory requirements implemented by FSIS in 
2004 that banned SRMs from the human food supply in the United States, 
and we stated that the Canadian Government had established similar 
safeguards in Canada.
    Consequently, we provided in Sec.  94.19 of the regulations that 
meat, meat byproducts, and meat food products derived from bovines are 
eligible for importation from BSE minimal-risk regions if the following 
conditions, as well as all other applicable requirements of the 
regulations, are met:
     The commodity is derived from bovines that have been 
subject to a ruminant feed ban equivalent to the requirements 
established by the U.S. Food and Drug Administration at 21 CFR 
589.2000;
     The commodity is derived from bovines for which an air-
injected stunning process was not used at slaughter; and
     The SRMs and small intestine of the bovines from which the 
commodity was derived were removed at slaughter.
    Because there is negligible risk from bovine meat, meat byproducts, 
and meat food products that meet the above requirements, there is no 
science-based reason to require that such commodities be derived from 
bovines born on or after March 1, 1999. As long as the commodities meet 
the conditions listed above (with the exception of the condition 
regarding small intestine as discussed in this rule), the regulations 
will allow for their importation into the United States. We note that 
the OIE guidelines for trade in fresh meat and meat products from 
cattle from controlled risk regions (both Canada and the United States 
are classified as BSE controlled risk regions under the OIE guidelines) 
recognize the negligible risk presented by such products as long as 
SRMs are removed, and, therefore, the guidelines do not recommend that 
the date of birth of the animal from which the commodity was derived be 
a condition for such trade.

Comments Regarding the Partial Delay in Applicability of the January 
2005 Final Rule

    Issue: As discussed above in this document, in March 2005, APHIS 
published a final rule in the Federal Register that, pursuant to an 
announcement by the Secretary of Agriculture in February 2005, delayed 
the applicability of the provisions in our January 2005 final rule as 
they apply to the importation from Canada of meat, meat food products, 
and meat byproducts (other than liver) when derived from bovines 30 
months of age or older when slaughtered, as well as certain other 
bovine products when derived from bovines 30 months of age or older.
    A number of commenters either questioned whether the delay in 
applicability would be lifted if our January 2007 proposed rule were 
made final, or requested that the delay be lifted.
    Response: As discussed above, it is the Secretary's intent to 
remove the delay in applicability when this rule becomes effective.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be economically significant for the purposes of 
Executive Order 12866 and, therefore, has been reviewed by the Office 
of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis as required by Executive 
Order 12866 and a final regulatory flexibility analysis that examines 
the potential economic effects on small entities as required by section 
604 of the Regulatory Flexibility Act. The economic analysis is 
summarized below. Copies of the full analysis may be viewed on the 
APHIS Web site (http://www.aphis.usda.gov/newsroom/hot_issues/bse/index.shtml), or be obtained by contacting the persons listed under FOR 
FURTHER INFORMATION CONTACT.
    This rule will allow the importation, under certain conditions, of 
the following commodities from BSE minimal-risk regions (currently only 
Canada):
     Live bovines that were born on or after March 1, 1999;
     Bovine small intestines, minus the distal ileum;
     Bovine casings; and
     Bovine blood and blood products.
    APHIS has determined that the previous restrictions are not 
warranted by scientific research and evidence, and that they are 
unnecessary for maintaining a negligible risk (i.e., the likelihood of 
establishment and the potential impacts of cases that may occur even 
without establishment) to the United States via imports of live bovines 
and bovine products from such regions.
    Additionally, this rule removes the delay of applicability of 
provisions of our January 2005 final rule regarding the importation of 
meat, meat products, and meat byproducts derived from bovines in Canada 
that were 30 months of age or older when slaughtered.
    This regulatory impact analysis (RIA) addresses expected economic 
effects of allowing resumption of imports from Canada of the above 
commodities. Expected benefits and costs are examined in accordance 
with Executive Order 12866. Expected economic impacts for small 
entities are also evaluated, as required by the Regulatory Flexibility 
Act. Our analysis indicates that benefits of the rule will exceed costs 
overall. Effects for Canadian and other foreign entities are not 
addressed in this analysis. However, the Agency expects reestablished 
access to U.S. markets to benefit Canadian producers and suppliers of 
commodities included in the rule.

Analytical Approach

    The approach and models used in this analysis are the same as were 
applied in the preliminary RIA that we prepared for our January 2007 
proposed rule. Impacts for cattle for feeding or for immediate 
slaughter and impacts for beef are quantitatively modeled. Impacts for 
other affected commodities--breeding cattle including dairy, vealers 
and slaughter calves, bison, bovine casings and small intestine 
products, and bovine blood and blood products--are examined largely 
qualitatively. For the modeled cattle and beef, we project a 5-year 
baseline, 2008-2012, against which we measure expected price and 
welfare effects of projected levels of cattle and beef imports from 
Canada. We evaluate price and welfare effects for the three scenarios 
that were considered in the preliminary RIA, as follows:
     Scenario 1: Allow imports of Canadian cattle born on or 
after March 1, 1999;
     Scenario 2: Allow imports of Canadian cattle unrestricted 
by date of birth; and
     Scenario 3: The same as scenario 1, with the addition of 
the resumption of imports of beef from Canadian cattle

[[Page 53367]]

slaughtered at 30 months or older (called over-30-month, or OTM beef).
    As a fourth scenario, we consider imports of Canadian cattle 
unrestricted by date of birth, with the resumption of OTM beef imports. 
Projected imports under this scenario 4 are described, but the expected 
impacts are not evaluated, for reasons explained below.
    Beginning with baseline quantities and prices, we compute effects 
of the projected changes in imports from Canada for four commodity 
categories: Cull cattle/processing beef, feeder cattle, fed cattle, and 
fed beef. The resumption of cull cattle imports is expected to affect 
the slaughter mix in Canada, and that change in the slaughter mix will 
be reflected in changes in the mix of exports to the United States.
    As part of this adjustment, for example, we expect that more fed 
steers and heifers will be slaughtered in Canada and fewer will be 
exported to the United States than if cull cattle imports were not 
reestablished. Canada's cattle inventory increased rapidly following 
the diagnosis of BSE in a Canadian cow in May 2003 and Canada's 
subsequent loss of export markets for cattle and beef. In response, 
Canada's slaughter capacity expanded. Beginning in July 2005, with the 
resumption of imports by the United States of Canadian feeder cattle 
and fed cattle, some Canadian plants continued to utilize their 
expanded slaughter capacity by shifting to increased cull cattle 
slaughter. Canadian cull cattle slaughter would likely continue to 
expand if the United States were to remain closed to imports of 
Canadian cull cattle. However, with this rule, we can expect some 
substitution in Canada of cull cattle slaughter by fed cattle 
slaughter.
    Importation of fewer fed cattle from Canada, all things equal, will 
cause the price of fed cattle in the United States to rise. We estimate 
the expected increase in price and, because of the price rise, the 
decrease in the quantity of fed cattle demanded by U.S. slaughter and 
packing establishments and the increase in the quantity of fed cattle 
supplied by U.S. feedlots. The analysis yields measures of welfare 
change, which in this example are in terms of surplus losses for U.S. 
buyers and surplus gains for U.S. sellers of fed cattle.
    For each of the first three scenarios, we compute impacts for the 
modeled commodities using the Baseline Analysis System (BAS) model.\29\ 
Impacts are also summed for each scenario. The BAS model is a net 
trade, non-spatial partial equilibrium model. Partial equilibrium means 
that the model results are based on maintaining a commodity-price 
equilibrium in a limited portion of an overall economy. Commodities not 
explicitly included in the model are assumed to have a negligible 
influence on the results. The simple summation of the separate partial 
equilibrium results using the BAS model does not take into account 
market dynamics, but does provide a reasonable approximation of the 
combined welfare effects for each scenario.
---------------------------------------------------------------------------

    \29\ A complete description of the model is provided in: 
Forsythe, K.W. ``An Economic Model for Routine Analysis of the 
Welfare Effects of Regulatory Changes.'' V3.00. U.S. Department of 
Agriculture, Animal and Plant Health Inspection Service, Veterinary 
Services, Centers for Epidemiology and Animal Health. April 20, 2005 
(draft). http://www.aphis.usda.gov/peer_review/content/printable_version/bas_model_econOnly_apr20.pdf
---------------------------------------------------------------------------

    We also examine impacts more broadly using a multi-sector model 
that takes into account substitution among livestock products in 
response to relative price changes.\30\ This model maps interactions 
among the grain, animal, and animal products industries. It takes into 
account substitution among livestock products in response to relative 
price changes, incorporates foreign trade, and yields expected price 
and revenue effects. The simulated multi-sector impacts tend to be 
smaller than the BAS model results because the model linkages specified 
between the livestock production and processing sectors capture at 
least some of the flexibility that industry enterprises exhibit when 
adjusting to supply shocks. These results support our expectation that 
broader impacts of the rule will be limited.
---------------------------------------------------------------------------

    \30\ Four examples of studies based on this type of model are: 
Paarlberg, P.L., A.H. Seitzinger, and J.G. Lee, ``Economic Impacts 
of Regionalization of a Highly Pathogenic Avian Influenza Outbreak 
in the United States,'' Journal of Agricultural and Applied 
Economics, forthcoming. Paarlberg, P.L. ``Agricultural Export 
Subsidies and Intermediate Goods Trade,'' American Journal of 
Agricultural Economics. 77, 1(1995): 119-128. Paarlberg, P.L., J.G. 
Lee, and A.H. Seitzinger. ``Potential Revenue Impact of an Outbreak 
of Foot-and-Mouth Disease in the United States,'' Journal of the 
American Veterinary Medical Association. 220, 7(April 1, 2002): 988-
992. Sanyal, K.K. and R.W. Jones. ``The Theory of Trade in Middle 
Products,'' American Economic Review. 72(1982): 16-31.
---------------------------------------------------------------------------

    Baseline quantities and prices and imports from Canada have been 
projected by staff of USDA ERS, Market and Trade Economics Division, 
Animal Products, Grains, and Oil Seeds Branch, based on their expert 
knowledge and reference to ``USDA Agricultural Baseline Projections to 
2016,'' United States Department of Agriculture, Interagency 
Agricultural Projections Committee, Baseline Report OCE-2007-1, 
February 2007.\31\
---------------------------------------------------------------------------

    \31\ http://www.usda.gov/oce/commodity/ag_baseline.htm
---------------------------------------------------------------------------

Projected Imports From Canada

    Scenario 1. Table A shows the projected changes in cattle and fed 
beef imports from Canada under scenario 1 (in which imports of Canadian 
cattle born on or after March 1, 1999, are allowed). Under this 
scenario, cull cattle imports from Canada are projected to total 
104,000 head in 2008 and average 147,800 head over the 5-year period of 
analysis. These import numbers are considerably smaller than were 
projected in the preliminary RIA because we now have a better 
understanding of the extent to which the birth-date restriction and 
age-verification requirement may limit the number of cull cattle 
eligible for import. Annual declines in feeder cattle and fed cattle 
imports are projected to average 6,800 head and 56,800 head, 
respectively. These declines correspond to projected changes in the 
overall Canadian cattle inventory, with the import volumes for fed 
cattle further adjusted downward to reflect greater competition from 
Canadian packers due to the resumption of U.S. imports of cull cattle. 
Yearly fed beef imports are projected to increase by an average of 45.8 
million pounds, carcass weight equivalent.
    All of the changes under scenario 1 are small when compared to the 
commodities' projected U.S. baseline supplies. The changes in imports 
for feeder cattle, fed cattle, and fed beef imports, in particular, are 
projected to be only fractions of 1 percent of baseline supplies. Under 
scenario 1, the number of cull cattle projected to be imported in 2008 
is less than 2 percent of projected U.S. baseline cull cattle slaughter 
quantities. Over the period of analysis, cull cattle imports are 
projected to average 2.5 percent of baseline quantities. Cull cattle 
imports are projected to increase in the latter years of the analysis, 
and even more so in subsequent years, as higher percentages of Canada's 
cull cattle inventory are able to be verified as having been born on or 
after March 1, 1999. A relative increase in the number of cull cattle 
imported over time is projected to be associated with, in turn, a 
relative decrease in the quantity of fed cattle imports and a relative 
increase in the quantity of fed beef imports.
    Baseline projections over the 5-year period, 2008-2012, show the 
United States importing a little over 40 percent of its supply of 
processing beef. A share

[[Page 53368]]

of the cull cattle imported from Canada will yield processing beef that 
will substitute for processing beef that otherwise would be imported 
from other countries, while a share of the imported cull cattle will 
yield processing beef that will replace a quantity of processing beef 
that would otherwise be domestically supplied, as U.S. producers 
respond to lower prices. The remaining share of cull cattle imports 
will yield processing beef that will represent a net increase in U.S. 
processing beef supplies.
    We use 25 percent as the percentage of cull cattle imports from 
Canada projected to displace U.S. processing beef imports from 
elsewhere. The 25 percent share is estimated using the multi-sector 
model and takes into account the interactions of the beef processing 
sector with the beef cattle and dairy cattle sectors. For comparison, 
we also compute price and welfare effects assuming that 50 percent of 
cull cattle imported from Canada displace processing beef imports, and 
assuming, alternatively, that none of the imported cull cattle displace 
processing beef imports.
    Scenario 2. In Table B, we show the projected changes in cattle and 
fed beef imports from Canada under scenario 2 (in which imports of 
Canadian cattle unrestricted by birth date are allowed). Under this 
scenario, imports of cull cattle and changes in imports of fed cattle 
and fed beef are all projected to be much larger than in scenario 1. 
Feeder cattle imports are projected to be the same under all of the 
scenarios. Projected cull cattle imports in scenario 2 average 459,800 
head per year over the period of analysis, or 7.8 percent of U.S. 
baseline slaughter quantities. This amount is more than three times 
cull cattle imports projected in scenario 1. The fed cattle and fed 
beef changes remain a fraction of 1 percent of the U.S. baseline 
supplies, but are also larger. The increased number of cull cattle 
imported in this scenario is projected to be associated with larger 
declines in fed cattle imports and larger increases in the fed beef 
imports. We again estimate that 25 percent of cull cattle imports from 
Canada under this scenario displace processing beef imports from other 
sources. Price and welfare analyses assuming that 50 percent of the 
imported cull cattle displace processing beef imports and that none of 
the cull cattle displace processing beef imports are also presented.
    Scenario 3. Table C shows the projected changes in cattle and beef 
imports from Canada under scenario 3 (in which imports of Canadian 
cattle born on or after March 1, 1999, are allowed and imports of OTM 
beef resume). In scenario 3, impacts derive from the resumption of OTM 
beef imports as well as the cull cattle imports from Canada. Projected 
cull cattle imports are lower than in scenario 1 (averaging 106,000 
head per year over the 5-year period, compared to 147,800 head) because 
of the entry of OTM beef. Similarly, changes in projected fed cattle 
and fed beef imports are somewhat smaller than the changes projected in 
scenario 1. Processing beef imports from Canada under scenario 3 are 
projected to average 254.6 million pounds per year, carcass weight 
equivalent, or about 4.1 percent of the U.S. baseline supply. The 
quantity of processing beef imported is projected to decline and the 
quantity of cull cattle imported is projected to increase in the latter 
years of the 5-year period, as an increasing number of cull cattle 
become eligible for importation--i.e., can be verified as having been 
born on or after March 1, 1999. Under scenario 3, and considering 
imports of cull cattle (based on the cattle's processing beef 
equivalence) and processing beef as a single market, 77 percent of cull 
cattle and processing beef imports from Canada are projected to enter 
the United States as OTM beef over the 5-year period of the analysis, 
while 23 percent of these imports are projected to enter as cull 
cattle. Consistent with scenarios 1 and 2, we use 25 percent as the 
share of the cull cattle and OTM beef imports from Canada that 
displaces processing beef imports from other countries. We also present 
the price and welfare effects assuming that either 50 percent or none 
of the cull cattle and OTM beef imports from Canada displace processing 
beef imports from elsewhere.
    Scenario 4. In table D, we show the projected changes in cattle and 
fed beef imports from Canada under scenario 4 (in which imports of 
Canadian cattle unrestricted by birth date are allowed and imports of 
OTM beef resume). As in scenario 2, imports of cull cattle and changes 
in imports of fed cattle and fed beef are all projected to be larger 
than in scenarios 1 and 3.
    Projected cull cattle imports in scenario 4 average 328,200 head 
per year over the period of analysis, or 5.5 percent of U.S. baseline 
slaughter quantities. The fed cattle and fed beef changes remain a 
fraction of 1 percent of the U.S. baseline supplies.

 Table A.--Projected Changes in Imports of Cull Cattle, Feeder Cattle, Fed Cattle, Fed Beef, and Processing Beef
From Canada Under Scenario 1, and Projected Changes in Imports From Canada as a Percentage of the Projected U.S.
                                          Baseline Supplies, 2008-2012
----------------------------------------------------------------------------------------------------------------
                                                                       2008     2009     2010     2011     2012
----------------------------------------------------------------------------------------------------------------
Projected changes in imports from Canada:
    Cull cattle (thousand head)....................................      104      110      113      187      225
    Feeder cattle (thousand head)..................................       -1        9       -5      -16      -21
    Fed cattle (thousand head).....................................      -30       -4      -43      -93     -114
    Fed beef (million pounds, carcass weight equivalent)...........       24        3       35       75       92
    Processing beef (million pounds, carcass weight equivalent)....        0        0        0        0        0
Projected changes in imports from Canada as a percentage of the
 projected U.S. baseline supply:
    Cull cattle....................................................     1.8%     1.9%     1.9%     3.1%     3.7%
    Feeder cattle..................................................      nil      nil      nil      nil    -0.1%
    Fed cattle.....................................................    -0.1%      nil    -0.1%    -0.3%    -0.4%
    Fed beef.......................................................     0.1%      nil     0.2%     0.3%     0.4%
    Processing beef................................................        0        0        0        0        0
----------------------------------------------------------------------------------------------------------------


[[Page 53369]]


 Table B.--Projected Changes in Imports of Cull Cattle, Feeder Cattle, Fed Cattle, Fed Beef, and Processing Beef
From Canada Under Scenario 2, and Projected Changes in Imports From Canada as a Percentage of the Projected U.S.
                                          Baseline Supplies, 2008-2012
----------------------------------------------------------------------------------------------------------------
                                                                       2008     2009     2010     2011     2012
----------------------------------------------------------------------------------------------------------------
Projected changes in imports from Canada:
    Cull cattle (thousand head)....................................      459      459      459      460      462
    Feeder cattle (thousand head)..................................       -1        9       -5      -16      -21
    Fed cattle (thousand head).....................................     -119      -91     -129     -161     -173
    Fed beef (million pounds, carcass weight equivalent)...........       96       74      105      131      140
    Processing beef (million pounds, carcass weight equivalent)....        0        0        0        0        0
Projected changes in imports from Canada as a percentage of the
 projected U.S. baseline supply:
    Cull cattle....................................................     8.2%     7.8%     7.6%     7.6%     7.6%
    Feeder cattle..................................................      nil      nil      nil      nil     -0.1
    Fed cattle.....................................................    -0.4%    -0.3%    -0.4%    -0.5%    -0.6%
    Fed beef.......................................................     0.4%     0.3%     0.5%     0.6%     0.6%
    Processing beef................................................        0        0        0        0        0
----------------------------------------------------------------------------------------------------------------


 Table C.--Projected Changes in Imports of Cull Cattle, Feeder Cattle, Fed Cattle, Fed Beef, and Processing Beef
 From Canada Under Scenario 3 and Projected Changes in Imports From Canada as a Percentage of the Projected U.S.
                                          Baseline Supplies, 2008-2012
----------------------------------------------------------------------------------------------------------------
                                                                       2008     2009     2010     2011     2012
----------------------------------------------------------------------------------------------------------------
Projected changes in imports from Canada:
    Cull cattle (thousand head)....................................       75       79       81      134      161
    Feeder cattle (thousand head)..................................       -1        9       -5      -16      -21
    Fed cattle (thousand head).....................................      -23        4      -34      -80      -98
    Fed beef (million pounds, carcass weight equivalent)...........       18       -3       28       65       79
    Processing beef (million pounds, carcass weight equivalent)....      277      273      272      234      217
Projected changes in imports from Canada as a percentage of the
 projected U.S. baseline supply:
    Cull cattle....................................................     1.3%     1.3%     1.3%     2.2%     2.7%
    Feeder cattle..................................................      nil      nil      nil      nil     -0.1
    Fed cattle.....................................................    -0.1%      nil    -0.1%    -0.3%    -0.3%
    Fed beef.......................................................     0.1%      nil     0.1%     0.3%     0.3%
    Processing beef................................................     4.7%     4.5%     4.4%     3.7%     3.4%
----------------------------------------------------------------------------------------------------------------


 Table D.--Projected Changes in Imports of Cull Cattle, Feeder Cattle, Fed Cattle, Fed Beef, and Processing Beef
From Canada Under Scenario 4, and Projected Changes in Imports From Canada as a Percentage of the Projected U.S.
                                          Baseline Supplies, 2008-2012
----------------------------------------------------------------------------------------------------------------
                                                                       2008     2009     2010     2011     2012
----------------------------------------------------------------------------------------------------------------
Projected changes in imports from Canada:
    Cull cattle (thousand head)....................................      328      328      327      328      330
    Feeder cattle (thousand head)..................................       -1        9       -5      -16      -21
    Fed cattle (thousand head).....................................      -86      -58      -96     -129     -140
    Fed beef (million pounds, carcass weight equivalent)...........       70       47       78      104      114
    Processing beef (million pounds, carcass weight equivalent)....       94       94       94       94       95
Projected changes in imports from Canada as a percentage of the
 projected U.S. baseline supply:
    Cull cattle....................................................     5.8%     5.6%     5.4%     5.4%     5.4%
    Feeder cattle..................................................      nil      nil      nil      nil    -0.1%
    Fed cattle.....................................................    -0.3%    -0.2%    -0.3%    -0.4%    -0.5%
    Fed beef.......................................................     0.3%     0.2%     0.3%     0.5%     0.5%
    Processing beef................................................     1.6%     1.5%     1.5%     1.5%     1.5%
----------------------------------------------------------------------------------------------------------------

Effects for Commodities Not Analyzed Using the BAS Model

    Five categories of commodities that will be affected by this rule 
have not been included in the modeled quantitative analysis described 
above. They are: Breeding cattle, including dairy; vealers and 
slaughter calves; bison; bovine casings and small intestine products; 
and bovine blood and blood products. Projected imports of breeding 
cattle including dairy, and projected changes in imports of vealers, 
slaughter calves, and bison, are relatively small, suggesting that 
impacts on affected U.S. entities will not be significant. For bovine 
casings, small intestine products, and blood and blood products, the 
analysis is constrained by a scarcity of information about the 
quantities that would be imported and levels of U.S. production and 
consumption.
    With regard to dairy producers, we do not expect imports of dairy 
cattle from Canada to add significantly to the U.S. herd, but rather to 
serve as an additional

[[Page 53370]]

source of replacement animals. From 1992 to 2002, U.S. producers 
annually raised about 4.1 million dairy replacement heifers and about 
5.9 million beef replacement heifers. The average number of Canadian 
breeding cattle imported during that period (including bulls) totaled 
only 0.5 percent of these combined quantities. The breeding cattle 
imports from Canada during this period represented about 1.1 percent of 
dairy heifer replacements and less than 0.1 percent of beef heifer 
replacements. Imports of dairy cows and heifers from Canada are 
projected to be similar to their historic levels, 1992-2002, averaging 
47,800 head per year over the period of analysis in all of the 
scenarios.
    Analysis using the multi-sector model indicates that, in scenario 
3, dairy producers may experience price declines of 1.3 to 1.7 percent 
for dairy cattle due to the small number projected to be imported from 
Canada. These imports translate into an increase in U.S. milk 
production of 0.1 percent or less, and a decline in the price of milk 
and increase in consumer surplus of less than 0.1 percent. As sellers 
of cull cattle, dairy producers as well as beef producers are expected 
to be negatively affected by the price decline for cull cattle due to 
this rule.
    We expect market effects for vealers and slaughter calves to be 
insignificant, given the small change in the number projected to be 
imported from Canada. The decline in imports is projected in scenario 3 
to average only 6 percent, or 3,000 head per year.
    A larger number of bison are projected to be imported than was 
projected in the preliminary RIA. Reestablished imports of Canadian 
breeding bison will be the principal impact of this rule for that 
industry. Yearly imports of breeding bison are projected to average 
1,200 head, and are expected to represent about 1 percent of U.S. 
breeding bison, assuming the composition of the national bison herd is 
similar to that of the national cattle herd.
    This rule may directly affect the U.S. supply of bovine casings and 
small intestine products through resumption of imports from Canada, and 
may affect it indirectly through changes in U.S. cattle slaughter 
numbers and the reestablished importation of Canadian bovine small 
intestines, minus the distal ileum. For scenario 3, the annual supply 
of bovine casings produced from additional U.S. cattle slaughter is 
projected to increase on average over the period of analysis by less 
than 0.2 percent.
    Fetal bovine serum (FBS) is the most important blood product that 
will be affected by this rule. Resumption of commercial imports of FBS 
from Canada, directly as serum and indirectly through increased U.S. 
pregnant cow slaughter, is expected to benefit FBS users, given current 
strong demand for this blood product in the United States.

Expected Impacts for Modeled Commodities

    In this summary, prices and welfare impacts are expressed in 2007 
dollars; price and quantity averages and percentage averages are over 
the 5-year period of analysis, 2008-2012; annualized values are 
discounted at 3 percent; and beef prices and quantities are in carcass 
weight equivalent. Percentage changes in prices and estimated welfare 
effects are shown in table E.
    Scenario 1. In this scenario, buyers of cull cattle and processing 
beef can be expected to benefit from welfare gains and sellers of cull 
cattle and processing beef can be expected to bear welfare losses due 
to the cull cattle imports. For this commodity, the estimated 
annualized consumer gains are $90.3 million, producer losses are $53.2 
million, and net benefits are $37.1 million.
    Welfare changes for the cull cattle/processing beef category 
dominate the modeled effects in all of the scenarios. The relatively 
large impacts are not unexpected, given that this is the one modeled 
commodity category for which imports from Canada would be newly 
reestablished and projected changes from the baseline are much larger 
than for the other commodities. The numbers of cull cattle projected to 
be imported in scenario 1, averaging 124,800 cows and 23,000 bulls and 
stags per year, are much larger than the projected average annual 
declines in imports of Canadian fed cattle (56,800 head) and feeder 
cattle (6,800 head).
    Another reason the welfare effects computed for the cull cattle/
processing beef category are large is the inelastic demand (-0.40) 
compared to the price elasticities of demand--i.e., buyers' 
responsiveness to changes in price--for the other modeled commodities 
(feeder cattle, -0.88; fed cattle, -0.76; fed beef, -0.60). In the 
preliminary RIA, we examined the significance of processing beef's more 
inelastic demand by considering welfare changes for the cull cattle/
processing beef category when a price elasticity of demand of -0.60 is 
used, that is, the same elasticity as for fed beef. This exercise found 
that all impacts--consumer gains, producer losses, net benefits, and 
price declines--are reduced by nearly one-fifth when a price elasticity 
of demand of -0.60 is used in place of -0.40. The price elasticity of 
demand is an important determinant of the magnitude of welfare and 
price changes for the cull cattle/processing beef category.
    Lastly, the large difference between consumer welfare gains and 
producer welfare losses for the cull cattle/processing beef category 
can be attributed to the fact that the United States is projected to 
import about 40 percent of its supply of processing beef over the 
period of analysis. In modeling the welfare effects, demand (defined as 
U.S. consumption) is much larger than supply (defined as U.S. 
production minus exports). Consequently the change in consumer surplus 
is large compared to the change in producer surplus because the effects 
are estimated only for U.S. entities.
    Slightly fewer feeder cattle are projected to be imported from 
Canada in scenario 1 than would otherwise enter, and the analysis 
indicates small gains in producer welfare (higher prices and less 
competition from Canadian suppliers) and small losses in consumer 
welfare for this commodity (higher prices and fewer feeder cattle 
available for purchase). Estimated annualized values are producer gains 
of $3.6 million, consumer losses of $3.8 million, and net losses of 
$0.2 million.
    As with feeder cattle, fewer fed cattle are projected to be 
imported under scenario 1 than would otherwise be imported. Once again, 
producers (sellers of fed cattle for slaughter) would benefit from 
welfare gains and consumers (buyers of fed cattle for slaughter) would 
bear welfare losses. Estimated annualized values are producer gains of 
$43.6 million, consumer losses of $44.7 million, and net losses of 
about $1.1 million.
    Scenario 1 is projected to result in increased imports of Canadian 
fed beef ranging from an additional 3 million pounds in 2009 to 92 
million pounds in 2012. Estimated annualized values are consumer gains 
of $48.8 million, producer losses of $46.8 million, and net gains of $2 
million.
    The analysis shows annualized combined welfare changes under 
scenario 1 as consumer gains of $90.6 million and producer losses of 
$52.7 million, yielding net benefits of $37.9 million. As can be seen 
in table E, the combined annualized values of consumer welfare losses 
for feeder cattle and fed cattle are similar to the consumer welfare 
gains for fed beef. Combined consumer welfare gains are very similar to 
the consumer welfare gains estimated for the cull cattle/processing 
beef category. A similar but opposite outcome is evident with

[[Page 53371]]

respect to producer welfare changes, with combined gains for feeder 
cattle and fed cattle somewhat larger than the producer welfare losses 
for fed beef. The result is combined producer welfare losses that are 
close to the producer welfare losses estimated for cull cattle/
processing beef. Under scenario 1, the combined annualized net welfare 
benefits, $37.9 million, are only slightly more than the $37.1 million 
in net benefits estimated for cull cattle/processing beef.

  Table E.--Comparison of Percentage Price Changes and Annualized Welfare Effects for Scenarios 1, 2, and 3 by
                      Commodity Category, 2008-2012, Discounted at 3 Percent, 2007 Dollars
----------------------------------------------------------------------------------------------------------------
                                                    Percentage       Change in       Change in
       Commodity category            Scenario        change in       consumer        producer       Net welfare
                                                       price          welfare         welfare         change
----------------------------------------------------------------------------------------------------------------
                                                                                 Thousand dollars
                                                                 -----------------------------------------------
Cull cattle/Processing beef.....               1           -1.4%          90,307         -53,207          37,100
                                               2           -4.5%         286,936        -165,615         121,320
                                               3           -4.5%         286,912        -165,603         121,308
Feeder cattle...................               1             nil          -3,795           3,605            -190
                                               2             nil          -3,795           3,605            -190
                                               3             nil          -3,795           3,605            -190
Fed cattle......................               1            0.1%         -44,703          43,636          -1,066
                                               2            0.3%        -107,513         105,101          -2,412
                                               3            0.1%         -36,263          35,388            -874
Fed beef........................               1           -0.1%          48,800         -46,757           2,044
                                               2           -0.3%         117,459        -112,426           5,033
                                               3           -0.1%          39,791         -38,131           1,660
Categories combined.............               1  ..............          90,609         -52,723          37,888
                                               2  ..............         293,087        -169,335         123,751
                                               3  ..............         286,645        -164,741        121,904
----------------------------------------------------------------------------------------------------------------
The three import scenarios considered in this table are (1) Canadian cattle born on or after March 1, 1999; (2)
  Canadian cattle unrestricted by date of birth; and (3) Canadian cattle born on or after March 1, 1999, plus
  resumption of imports of meat from Canadian cattle slaughtered at 30 months or older. The percentage change in
  price is the average annual change over the 5-year period. Welfare changes may not sum due to rounding.

    Scenario 2. Because of the significantly larger number of cull 
cattle projected to be imported in scenario 2, the estimated price and 
welfare effects are also much larger than for scenario 1. Table E shows 
these differences, with the percentage changes in price about three 
times greater in all cases (other than for feeder cattle, for which 
imports are projected to be the same in all scenarios). Whereas the 
combined net benefit in scenario 1 is estimated to be an annualized 
$37.9 million, in scenario 2 it is $123.8 million.
    As described in the risk assessment, transmission of BSE requires 
that bovines ingest feed that contains the infectious agent. The OIE 
establishes standards for the international trade in animals and animal 
products. It recommends that cattle be imported from a controlled risk 
region for BSE only if the cattle selected for export were born after 
that date from which a ban on the feeding of ruminants with meat-and-
bone meal and greaves (the residue left after animal fat or tallow has 
been rendered) derived from ruminants had been effectively enforced. In 
May 2007, the OIE classified both the United States and Canada as BSE 
controlled risk regions.
    On August 4, 1997, Canada issued regulations prohibiting the use of 
mammalian protein in ruminant feeds. Implementation of the feed ban was 
a gradual process, with producers, feed mills, retailers, and feed 
manufacturers given grace periods before they were required to be in 
full compliance with the regulations. It is believed that this 
implementation period may have lasted 6 months, making February 1998 a 
more realistic date on which the ban can be considered to have gone 
into effect.
    APHIS considers that a period of 1 year following the full 
implementation of the feed ban allowed sufficient time for the measures 
taken by Canada to have their desired effect. Therefore, APHIS 
concludes that there is an extremely low likelihood that cattle born in 
Canada on or after March 1, 1999, will have been exposed to the BSE 
agent via feed. Therefore, these animals have an extremely low 
likelihood of being infected and can be imported into the United States 
for any purpose.
    We do not have a quantitative estimate of the additional risk posed 
by importation of Canadian cattle born before March 1, 1999. The 
importance of a feed ban as a risk mitigation measure is demonstrated 
in science and experience, and is incorporated into the OIE guidelines. 
We conclude that there could be some degree of increased likelihood of 
BSE infectivity entering the United States via imports of live bovines 
from Canada under scenario 2, compared to the very low likelihood posed 
in scenario 1, because of the greater likelihood of cattle born prior 
to the effective enforcement of a feed ban having been exposed to 
infectivity.
    Scenario 3. The price and welfare effects under scenario 3 are 
similar to the effects under scenario 2 for cull cattle/processing 
beef, but more like the scenario 1 effects for fed cattle and fed beef 
(table E). This outcome is expected because scenario 3 includes 
reestablishment of OTM beef imports from Canada. Combined net welfare 
benefits for scenarios 2 and 3 are very similar, with the projected 
cull cattle imports in scenario 2 and the projected imports of cull 
cattle and OTM beef in scenario 3 both based on cattle and beef import 
quantities prior to May 2003. The additional quantities of cull cattle/
processing beef in scenarios 2 and 3 are essentially the same, entering 
as live cattle in scenario 2 and as beef in scenario 3.
    The BSE risk mitigations under scenario 3 are comparable to those 
under scenario 1. The restriction on live bovine imports by date of 
birth, age verification, and other safeguard measures are the same in 
both cases. Consequently, as in scenario 1, the likelihood of BSE 
infectivity entering the United States via imports of live bovines from 
Canada in this scenario is

[[Page 53372]]

extremely low. Resumption of OTM beef imports from Canada will not 
affect the likelihood of BSE infectivity entering the United States 
because SRMs will be removed and disposed of in Canada.
    Scenario 4. A fourth scenario, as indicated above, would be to 
allow entry of Canadian cattle unrestricted by birth date, along with 
resumption of OTM beef imports from Canada. A quantitative analysis of 
expected price and welfare effects for this particular scenario was not 
performed. When we compare projected imports under this scenario with 
those projected for scenario 3, we find the differences in combined 
cattle and beef imports to be very small and conclude that the welfare 
effects for this scenario would be very similar to the effects of 
scenario 3.
    Cull cattle imports from Canada are projected to average about 
328,000 head per year under scenario 4, compared to 106,000 head per 
year under scenario 3. Conversely, annual processing beef imports under 
scenario 4 are projected to average 94 million pounds, carcass weight 
equivalent, compared to 255 million pounds for scenario 3.
    Similar differences between the two scenarios are projected for fed 
cattle and fed beef imports. The larger number of cull cattle that 
would be imported from Canada under scenario 4 could be expected to be 
associated with increased fed cattle slaughter in Canada, with fewer 
fed cattle and more fed beef exported to the United States. Under 
scenario 4, fed cattle imports from Canada are projected to average 
about 624,000 head per year, compared to 679,000 head per year under 
scenario 3. Annual fed beef imports under scenario 4 are projected to 
average 992 million pounds, compared to 947 million pounds for scenario 
3.
    The average annual net difference between scenarios 3 and 4 in 
projected cull cattle and processing beef imports from Canada, after 
converting the cull cattle to processing beef, is about 700,000 pounds 
(330.8 million pounds in scenario 3, and 330.1 million pounds in 
scenario 4). This amount represents about 0.2 percent of projected cull 
cattle/processing beef imports under scenario 3. For fed cattle and fed 
beef imports from Canada, the average annual net difference between 
scenarios 3 and 4 after converting the fed cattle to fed beef, is about 
1.3 million pounds (1,483.7 million pounds in scenario 3, and 1,485.0 
million pounds in scenario 4). This amount represents about 0.1 percent 
of the projected fed cattle and fed beef imports under scenario 3. 
Hence, we conclude that the overall welfare effects of scenario 4 would 
be very similar to those for scenario 3.

Effects on Small Entities

    There were no significant issues raised in public comment on the 
initial regulatory flexibility analysis (RFA) for this rulemaking. 
However, as described below, the majority of businesses that may be 
affected by this rule are small entities. Therefore, while none of the 
comments received on the proposed rule raised specific issues regarding 
the initial RFA, comments on the preliminary RIA can be inferred to 
express small-entity concerns.
    Topics that received public comment and that concerned the 
estimated economic impacts of the proposed rule included modeling 
issues; the timing of the rule's implementation; consequences of a BSE 
occurrence; and impacts of the rule for consumers, cow-calf producers, 
the dairy industry, and the packing industry, and on beef exports. 
These comments are addressed in the Agency's responses that are 
included as part of the final rule.
    Small entities comprise the majority of the establishments engaged 
in the production, processing, and sale of the commodities affected by 
this rule. These small entities number at least in the hundreds of 
thousands, with cow-calf and dairy producers comprising the largest 
single industry sector share. The entities are classified within the 
following industries according to the North American Industry 
Classification System: Beef Cattle Ranching and Farming (NAICS 112111), 
Dairy Cattle and Milk Production (NAICS 112120), All Other Animal 
Production (NAICS 112990), Cattle Feedlots (NAICS 112112), Animal 
(except Poultry) Slaughtering (NAICS 311611), Meat Processed from 
Carcasses (NAICS 311612), Meat and Meat Product Merchant Wholesalers 
(NAICS 424470), Supermarkets and Other Grocery (except Convenience) 
Stores (NAICS 445110), Meat Markets (NAICS 445210), In-Vitro Diagnostic 
Substance Manufacturing (NAICS 325413), and Biological Product (except 
Diagnostic) Manufacturing (NAICS 325414).
    We are unable to determine the extent to which cull cattle prices 
may fall because of the rule. Assuming that the price decline for cull 
cattle is proportional to the estimated price decline for processing 
beef, cow-calf and dairy producers in scenario 3 may experience a fall 
in price for cull cattle of 4.7 percent in 2008, and an average price 
decline of 4.5 percent ($4.61 per cwt). To place this average price 
decline in perspective, we consider the effect it may have on gross 
earnings of small-entity cow-calf operations. Based on data from the 
2002 Census of Agriculture, the average value of cattle and calves sold 
by small-entity beef cow operations was about $26,600.\32\ The 
projected 2008 price for a culled cow is $54.19 per cwt.\33\ Assuming 
the cow weighs 1,100 pounds, its price in 2008 would be $596.09 per 
head. A 4.7 percent decline would result in a price of $568.07. 
Presumably, most of a cow-calf operation's revenue is earned from the 
sale of calves. If one-half of an operation's revenue were to derive 
from the sale of cull cattle, the reduction in revenue attributable to 
the decline in the price of cull cattle in scenario 3 would total about 
$625 for the year.\34\
---------------------------------------------------------------------------

    \32\ USDA, NASS. 2002 Census of Agriculture, Volume 1, Chapter 
1, Table 16. The $26,000 average is for operations with fewer than 
1,000 head. http://www.nass.usda.gov/Census_of_Agriculture/index.asp
    \33\ Boning utility cow (Sioux Falls) nominal price.
    \34\ ($26,600/2) (0.047) = $625.10.
---------------------------------------------------------------------------

    For dairy enterprises, the expected price decline for cull cattle 
because of imports from Canada is expected to have a small effect on 
their incomes because most revenue (over 86 percent in 2002) is earned 
from the sale of milk and other dairy products.\35\ The average per 
animal value of cattle and calves sold by small-entity dairy cow 
operations in 2002 was about $453. A price decline of 4.7 percent, 
notwithstanding the fact that not all of the animals sold would be cull 
cattle, would mean a decrease in annual revenue for the average small-
entity dairy operation of about $1,040, assuming no change in the 
number of cattle sold.\36\ This forgone income would represent a 
decline in average revenue of about 0.6 percent.\37\
---------------------------------------------------------------------------

    \35\ USDA, NASS, 2002 Census of Agriculture, Volume 1, Chapter 
1, Table 17. For small-entity producers, revenue from cattle and 
calf sales totaled $1.7 billion and revenue from dairy product sales 
totaled $11.2 billion. http://www.nass.usda.gov/Census_of_Agriculture/index.asp
    \36\ In 2002, the average revenue from cattle sales for small-
entity dairy operations was $22,197 ($453 per head multiplied by 49 
head). ($22,197)(0.047) = $1,043.26.
    \37\ $1,043 divided by $175,912 (average income for small dairy 
farms from combined dairy product and cattle sales) equals 0.59 
percent.
---------------------------------------------------------------------------

    The scenario 3 analysis indicates that decreases in the price of 
fed beef due to increased fed beef imports from Canada are expected to 
be very small, resulting in a loss for the average meat packing and 
processing establishment of less than 0.2 percent of average revenue 
(18 cents per cwt, with projected baseline fed beef prices averaging 
$151.80 per cwt). Effects for those packers and processors that utilize 
processing beef will be larger, due to the resumption of cull cattle 
and OTM beef imports from

[[Page 53373]]

Canada. Annual prices of processing beef are expected to fall by an 
average of $4.61 per cwt in scenario 3. This decline in price will 
benefit establishments that use processing beef to produce ground beef 
for the wholesale market. Conversely, establishments that sell 
processing beef will be negatively affected by the expected price 
decline.
    In response to public comments on the preliminary RIA, we include 
an evaluation of welfare effects by industry sector for scenario 3. 
While this evaluation is admittedly broad, it provides an indication of 
the extent to which major sectors of the cattle and beef industries may 
be affected. We group the entities that we expect to be directly 
affected into four generalized categories: cow-calf and dairy 
producers, feedlot establishments, slaughter and packing 
establishments, and wholesaler and successive establishments. 
Admittedly, this simple categorization does not capture the many 
complexities of the cattle and beef industries, but it does provide a 
level of specification sufficient for examining expected effects for 
the industries' principal stages of economic activity. In reality, 
businesses combine the slaughter, packing, processing, and wholesaling 
functions in various ways. This consideration of sector-level effects 
indicates that cow-calf and dairy producers and slaughter and packing 
establishments are expected to incur net welfare losses, while feedlots 
and wholesalers are expected to accrue net welfare gains.
    Currently, bovines imported from Canada are restricted to animals 
that are slaughtered at less than 30 months of age. Bovines not 
imported for immediate slaughter must be moved from the port of entry 
to a feedlot in a sealed means of conveyance and from the feedlot to a 
recognized slaughtering establishment again in a sealed means of 
conveyance. The animals may not be moved to more than one feedlot. With 
this rule, these movement restrictions will no longer be imposed. 
Canadian bovines imported other than for immediate slaughter will be 
able to be moved any number of times to any destinations in unsealed 
means of conveyance.
    Under this rule, feeder bovines imported from BSE minimal-risk 
regions will not need to be accompanied by APHIS Form VS 17-130, which 
currently is used to identify the feedlot of destination. (The name of 
the individual responsible for the movement of an imported animal and 
individual identification of the animal will still be required 
information on the accompanying health certificate.) APHIS estimates 
that the time saved by entities no longer needing to acquire APHIS Form 
VS 17-130 will total approximately 40,000 hours per year.\38\ Also 
under this rule, bovines of Canadian origin moved from a U.S. feedlot 
to a slaughtering establishment will not need to be accompanied by 
APHIS Form VS 1-27. APHIS estimates the same total time savings by 
entities no longer needing to acquire APHIS Form VS 1-27: 40,000 hours 
per year.
---------------------------------------------------------------------------

    \38\ This approximation is based on 1,000 entities filling out 
Form VS 17-130 on 20 occasions per year, with each form requiring 
two hours. The estimated total time saved by not having to complete 
Form VS 1-27 is calculated on this same basis.
---------------------------------------------------------------------------

    Removal of these movement and paperwork requirements will benefit 
buyers and sellers of Canadian-origin bovines. Many of the 
beneficiaries are likely to be small entities, given their predominance 
among beef and dairy operations and feedlot establishments. Affected 
businesses will be able to take advantage of a broader range of 
transactional opportunities than previously. For example, the sale of a 
young steer first for backgrounding, then for confined feeding at one 
or more facilities, and finally for slaughter may enable the original 
and subsequent owners of the animal to better maximize returns compared 
to current marketing possibilities. While we are not able to quantify 
impacts of removing current movement restrictions on Canadian cattle 
imports, we expect their removal will benefit the cattle industry 
across-the-board.
    The Agency has identified alternatives to the rule and analyzed 
them in this RIA. We have found that the chosen alternative (scenario 
3) best strikes the balance of continuing to provide an acceptable 
level of protection against BSE infectivity entering the United States 
via imports of live bovine and bovine product imports, while removing 
unnecessary prohibitions on the importation of certain commodities from 
Canada. Without this rule, restrictions on U.S. importation of certain 
Canadian bovine commodities that are without scientific merit would 
continue. With this rule, importation of these Canadian commodities 
will be allowed to resume under certain conditions and the BSE risk to 
the United States via imports of live bovines and bovine products from 
Canada will be negligible.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule has been designated by the Administrator, Office of 
Information and Regulatory Affairs, Office of Management and Budget, as 
a major rule under the Small Business Regulatory Enforcement Fairness 
Act of 1996 (5 U.S.C. 801-808). Accordingly, the effective date of this 
rule has been delayed the required 60 days pending congressional 
review.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

National Environmental Policy Act

    An environmental assessment and finding of no significant impact 
have been prepared for this final rule. The environmental assessment 
provides a basis for the conclusion that the importation of live 
bovines and of bovine products as specified in this rule will not have 
a significant impact on the quality of the human environment. Based on 
the finding of no significant impact, the Decisionmaker of the Animal 
and Plant Health Inspection Service has determined that an 
environmental impact statement need not be prepared.
    The environmental assessment and finding of no significant impact 
were prepared in accordance with: (1) The National Environmental Policy 
Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) 
regulations of the Council on Environmental Quality for implementing 
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA 
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA 
Implementing Procedures (7 CFR part 372).
    The environmental assessment and finding of no significant impact 
may be viewed on the APHIS Web site (http://www.aphis.usda.gov/newsroom/hot_issues/bse/index.shtml), or be obtained by contacting the 
person listed under FOR FURTHER INFORMATION CONTACT. Copies of the 
environmental assessment and finding of no significant impact are also 
available for public inspection at USDA, room 1141, South Building, 
14th Street and Independence Avenue, SW., Washington, DC, between 8 
a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons 
wishing to inspect copies are requested to call ahead on (202) 690-2817 
to facilitate entry into the reading room. In addition, copies may be 
obtained by

[[Page 53374]]

writing to the individuals listed under FOR FURTHER INFORMATION 
CONTACT.

Paperwork Reduction Act

    This final rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

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Lloyd, S.E., J.M. Linehan, M. Desbruslais, S. Joiner, J. Buckell, S. 
Brandner, J.D. Wadsworth, and J. Collinge. (2004). Characterization 
of two distinct prion strains derived from bovine spongiform 
encephalopathy transmissions to inbred mice. J. of Gen Virology 
85(8):2471-2478.
Manuelidis, L., Z.-X. Yu, N. Banquero, and B. Mullins. (2007). Cells 
infected with scrapie and Creutzfeldt-Jakob disease agents produce 
intracellular 25-nm virus-like particles. Proc Natl Acad Sci. 
104(6): 1965-70. February 6. (http://www.pnas.org/cgi/reprint/104/6/1965)
Mintert, J. ``Measuring Beef Demand.'' Kansas State University 
Agricultural Experiment Station and Cooperative Extension Service, 
Presentation to the Beef Board in Atlanta, Georgia, November 2006. 
(http://www.agmanager.info/livestock/marketing/presentations/files/Mintert_Beef_Demand)
Office of Management and Budget (OMB). (2004). ``Final Information 
Quality Bulletin for Peer Review.'' A Memorandum for

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Heads of Departments and Agencies. M-05-03. The Office of Management 
and Budget, the Executive Office of the President, Washington, DC. 
December 16.
Research Triangle Institute (RTI). (2007). Peer Review of the 
Assessment of BSE Risk Associated with the Importation of Certain 
Additional Commodities from BSE Minimal Risk Regions (Canada). Final 
Report. March. (http://www.aphis.usda.gov/peer_review/peer_review_agenda.shtml)
Rice, J.A. (1988). Mathematical Statistics and Data Analysis. 
Pacific Grove, CA: Wadsworth & Brooks/Cole.
Saegerman, C., D. Berkvens, E. Vanopdenbosch, N. Speybroeck, P. 
Dechamps, M. Gouffaux, J. Penders, S. Roels, E. Thiry. (2004a). 
Epidemiology of Transmissible Spongiform Encephalopathies in Belgium 
and Europe. Transmissible Spongiform Encephalopathies: Creutzfeldt-
Jakob Disease, Bovine Spongiform Encephalopathy and Scrapie. 
Veterinary and Agrochemical Research Centre (CODA/CERVA) 
Creutzfeldt-Jakob Commission of the Superior Council of Hygiene. 
November 27. Brussels, Belgium. (http://www.var.fgov.be/pdf/1015_TSEDAY.pdf)
Spongiform Encephalopathy Advisory Committee (SEAC). (2004). Updated 
approach to assessing the future number of vCJD cases arising from 
relaxation of the OTM scheme. pp. 2-3. July 2. (http://www.seac.gov.uk/statements/OTM_statement_July04.pdf)
Spongiform Encephalopathy Advisory Committee (SEAC). (2005). SEAC 
Annual Report 2005. (http://www.seac.gov.uk/publicats/publicats.htm)
Statistics Canada. (2007). Cattle inventories, by province. Tables 
by Province or Territory. (http://www40.statcan.ca/z01/cs0003_e.htm)
Stevenson, M.A., R.S. Morris, A.B. Lawson, J.W. Wilesmith, J.B. 
Ryan, and R. Jackson. (2005). Area-level risks for BSE in British 
cattle before and after the July 1988 meat and bone meal feed ban. 
Preventative Veterinary Medicine. 69(1-2): 129-44.
Taylor, D.M., S.L. Woodgate, and M. J. Atkinson. (1995). 
Inactivation of the bovine spongiform encephalopathy agent by 
rendering procedures. Vet. Rec. 137(24): 605-610.
Taylor, D.M., S.L. Woodgate, A.J. Fleetwood, and R.J.G. Cawthorne. 
(1997). The effect of rendering procedures on scrapie agent. Vet. 
Rec. 141(25): 643-649.
Terry, L.A., S. Marsh, S.J. Ryder, S.A.C. Hawkins, G.A.H. Wells, and 
Y.I. Spencer. (2003). Detection of disease specific PrP in the 
distal ileum of cattle exposed orally to the agent of bovine 
spongiform encephalopathy. Vet. Rec. 152(13): 387-392.
United States Department of Agriculture (USDA). (2005). Assessment 
of the Canadian Feed Ban. February. (http://www.aphis.usda.gov/newsroom/hot_issues/bse/background)
United States Department of Agriculture (USDA). (2006). BSE Trade 
Ban Status as of July 28, 2006. (http://www.aphis.usda.gov/newsroom/hot_issues/bse/background)
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Disease Control and Prevention (CDC). (2007). BSE (Bovine Spongiform 
Encephalopathy, or Mad Cow Disease). May 18. (http://www.cdc.gov/ncidod/dvrd/bse/index.htm)
Vickner, S., D. Bailey, and A. Dustin. (2006). ``University-Retail 
Industry Research Partnerships as a Means to Analyze Consumer 
Response: The Case of Mad Cow Disease.'' Western Economics Forum 
5(2): 36-40.
Wells, G.A.H., M. Dawson, S.A.C. Hawkins, R.B. Green, I. Dexter, 
M.E. Francis, M.M. Simmons, A.R. Austin, and M.W. Horigan. (1994). 
Infectivity in the ileum of cattle challenged orally with bovine 
spongiform encephalopathy. Vet. Rec. 135(2): 40-41.
Wells, G.A.H., J. Spiropoulos, S.A.C. Hawkins, and S.J. Ryder. 
(2005). Pathogenesis of experimental bovine spongiform 
encephalopathy: pre-clinical infectivity in tonsil and observations 
on the distribution of lingual tonsil in slaughtered cattle. Vet 
Rec. 156(13): 401-407.
Wilesmith, J., R. Morris, M. Stevenson, R. Cannon, D. Prattley, and 
H. Benard. (2004). Development of a Method for Evaluation of 
National Surveillance Data and Optimization of National Surveillance 
Strategies for Bovine Spongiform Encephalopathy, A Project Conducted 
by the European Union TSE Community Reference Laboratory, Veterinary 
Laboratories Agency Weybridge, United Kingdom. (http://www.bsurve.com)
World Health Organization (WHO). (2002). (www.who.int/mediacentre/factsheets/fs113/en)
World Organization for Animal Health (OIE). (2006). Terrestrial 
Animal Health Code. Paris, OIE. (http://www.oie.int/eng/normes/mcode/en_sommaire.htm)
World Organization for Animal Health (OIE). (2006a). Terrestrial 
Animal Health Code Appendix 3.8.4, Articles 3.8.4.2 and 3.8.4.4. 
Surveillance for Bovine Spongiform Encephalopathy. OIE: Paris. 
(http://www.oie.int/eng/normes/mcode/en_chapitre_3.8.4.htm)
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Animal Health Code Chapter 1.1.1. General Definitions. Article 
1.1.1.1. OIE: Paris. (http://www.oie.int/eng/normes/mcode/en_chapitre_1.1.1.htm)
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reported cases of bovine spongiform encephalopathy (BSE) in farmed 
cattle worldwide (excluding the United Kingdom). (http://www.oie.int/eng/info/en_esbmonde.htm)
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incidence rate of bovine spongiform encephalopathy (BSE) in OIE 
Member Countries that have reported cases, excluding the United 
Kingdom. (http://www.oie.int/eng/info/en_esbincidence.htm)
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health status. Bovine spongiform encephalopathy. Resolution No. 
XXIV, Recognition of the Bovine Spongiform Encephalopathy Status of 
Member Countries. (http://www.oie.int/eng/info/en_statesb.htm)
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Atypical proteinase K-resistant prion protein (PrPres) 
Observed in an apparently healthy 23-month-old Holstein steer. 
Japanese Journal of Infectious Disease 56:221-222.

List of Subjects

9 CFR Part 93

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements.

9 CFR Part 94

    Animal diseases, Imports, Livestock, Meat and meat products, Milk, 
Poultry and poultry products, Reporting and recordkeeping requirements.

9 CFR Part 95

    Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping 
requirements, Straw, Transportation.

9 CFR Part 96

    Imports, Livestock, Reporting and recordkeeping requirements.

0
Accordingly, we are amending 9 CFR parts 93, 94, 95, and 96 as follows:

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND 
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS 
OF CONVEYANCE AND SHIPPING CONTAINERS

0
1. The authority citation for part 93 continues to read as follows:

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.


Sec.  93.405  [Amended]

0
2. In Sec.  93.405, paragraph (a)(4) is amended by removing the words 
``feedlot or recognized slaughtering establishment'' and adding in 
their place the words ``destination''.

0
3. Section 93.419 is amended as follows:
0
a. Paragraphs (b) and (c) are revised to read as set forth below.
0
b. Paragraph (d) is redesignated as paragraph (e).
0
c. A new paragraph (d) is added to read as set forth below.
0
d. In newly redesignated paragraph (e)(2), the reference to ``paragraph 
(d)(7)'' is removed and a reference to ``paragraph (e)(7)'' is added in 
its place.


Sec.  93.419  Sheep and goats from Canada.

* * * * *
    (b) If the sheep or goats are unaccompanied by the certificate

[[Page 53377]]

required by paragraph (a) of this section, or if they are found upon 
inspection at the port of entry to be affected with or exposed to a 
communicable disease, they shall be refused entry and shall be handled 
or quarantined, or otherwise disposed of, as the Administrator may 
direct.
    (c) Any sheep or goats imported from Canada must not be pregnant, 
must be less than 12 months of age when imported into the United States 
and when slaughtered, must be from a flock or herd subject to a 
ruminant feed ban equivalent to the requirements established by the 
U.S. Food and Drug Administration at 21 CFR 589.2000, and must be 
individually identified by an official Canadian Food Inspection Agency 
eartag, applied before the animal's arrival at the port of entry into 
the United States, that is determined by the Administrator to meet 
standards equivalent to those for official eartags in the United States 
as defined in Sec.  71.1 of this chapter and to be traceable to the 
premises of origin of the animal. No person may alter, deface, remove, 
or otherwise tamper with the individual identification while the animal 
is in the United States or moving into or through the United States, 
except that the identification may be removed at the time of slaughter. 
The animals must be accompanied by the certification issued in 
accordance with Sec.  93.405 that states, in addition to the statements 
required by Sec.  93.405, that the conditions of this paragraph have 
been met. Additionally, for sheep and goats imported for immediate 
slaughter, the certificate must state that the conditions of paragraphs 
(d)(1) through (d)(3) of this section have been met, and, for sheep and 
goats imported for other than immediate slaughter, the certificate must 
state that the conditions of paragraphs (e)(1) and (e)(2) of this 
section have been met.
    (d) Sheep and goats imported for immediate slaughter. Sheep and 
goats imported from Canada for immediate slaughter must be imported 
only through a port of entry listed in Sec.  93.403(b) or as provided 
for in Sec.  93.403(f) in a means of conveyance sealed in Canada with 
seals of the Canadian Government, and must be moved directly as a group 
from the port of entry to a recognized slaughtering establishment for 
slaughter as a group. The sheep and goats shall be inspected at the 
port of entry and otherwise handled in accordance with Sec.  93.408. 
The seals on the means of conveyance must be broken only at the port of 
entry by the APHIS port veterinarian or at the recognized slaughtering 
establishment by an authorized USDA representative. If the seals are 
broken by the APHIS port veterinarian at the port of entry, the means 
of conveyance must be resealed with seals of the U.S. Government before 
being moved to the recognized slaughtering establishment. The shipment 
must be accompanied from the port of entry to the recognized 
slaughtering establishment by APHIS Form VS 17-33, which must include 
the location of the recognized slaughtering establishment. 
Additionally, the sheep and goats must meet the following conditions:
    (1) The animals have not tested positive for and are not suspect 
for a transmissible spongiform encephalopathy;
    (2) The animals have not resided in a flock or herd that has been 
diagnosed with BSE; and
    (3) The animals' movement is not restricted within Canada as a 
result of exposure to a transmissible spongiform encephalopathy.
* * * * *

0
4. Section 93.420 is revised to read as follows:


Sec.  93.420  Ruminants from Canada for immediate slaughter other than 
bovines, sheep, and goats.

    The requirements for the importation of sheep and goats from Canada 
for immediate slaughter are contained in Sec.  93.419. The requirements 
for the importation of bovines from Canada for immediate slaughter are 
contained in Sec.  93.436. All other ruminants imported from Canada for 
immediate slaughter, in addition to meeting all other applicable 
requirements of this part, must be imported only through a port of 
entry listed in Sec.  93.403(b) or as provided for in Sec.  93.403(f) 
to a recognized slaughtering establishment for slaughter, in 
conveyances that must be sealed with seals of the U.S. Government at 
the port of entry. The seals may be broken only at a recognized 
slaughtering establishment in the United States by an authorized USDA 
representative. The shipment must be accompanied from the port of entry 
to the recognized slaughtering establishment by APHIS Form VS 17-33, 
which must include the location of the recognized slaughtering 
establishment. Such ruminants shall be inspected at the port of entry 
and otherwise handled in accordance with Sec.  93.408.

(Approved by the Office of Management and Budget under control 
number 0579-0277)


0
5. Section 93.436 is amended as follows:
0
a. Paragraphs (a) and (b) are revised to read as set forth below.
0
b. In paragraph (c), the reference to ``Sec. Sec.  93.419(c) and 
93.420'' is removed and a reference to ``Sec. Sec.  93.405 and 93.419'' 
is added in its place.


Sec.  93.436  Ruminants from regions of minimal risk for BSE.

* * * * *
    (a) Bovines for immediate slaughter. Bovines from a region listed 
in Sec.  94.18(a)(3) of this subchapter may be imported for immediate 
slaughter under the following conditions:
    (1) The bovines must have been born on or after a date determined 
by APHIS to be the date of effective enforcement of a ruminant-to-
ruminant feed ban in the region of export. For bovines imported from 
Canada, that date is March 1, 1999.
    (2) Each bovine must be individually identified by an official 
eartag of the country of origin, applied before the animal's arrival at 
the port of entry into the United States, that is determined by the 
Administrator to meet standards equivalent to those for official 
eartags in this chapter and to be traceable to the premises of origin 
of the animal. No person may alter, deface, remove, or otherwise tamper 
with the official identification while the animal is in the United 
States or moving into or through the United States, except that the 
identification may be removed at the time of slaughter;
    (3) The bovines must be accompanied by a certificate issued in 
accordance with Sec.  93.405 that states, in addition to the statements 
required by Sec.  93.405, that the conditions of paragraphs (a)(1) and 
(a)(2) of this section have been met;
    (4) The bovines must be imported only through a port of entry 
listed in Sec.  93.403(b) or as provided for in Sec.  93.403(f). The 
bovines shall be inspected at the port of entry and otherwise handled 
in accordance with Sec.  93.408;
    (5) The bovines must be moved directly from the port of entry to a 
recognized slaughtering establishment. Bovines imported from Canada 
must be moved to the slaughtering establishment in conveyances that are 
sealed with seals of the U.S. Government at the port of entry. The 
seals may be broken only at the recognized slaughtering establishment 
by an authorized USDA representative; and
    (6) The bovines must be accompanied from the port of entry to the 
recognized slaughtering establishment by APHIS Form VS 17-33.
    (b) Bovines for other than immediate slaughter. Bovines from a 
region listed in Sec.  94.18(a)(3) of this subchapter may be imported 
for other than immediate

[[Page 53378]]

slaughter under the following conditions:
    (1) The bovines must have been born on or after a date determined 
by APHIS to be the date of effective enforcement of a ruminant-to-
ruminant feed ban in the region of export. For bovines imported from 
Canada, that date is March 1, 1999.
    (2) The bovines must be permanently and humanely identified before 
arrival at the port of entry with a distinct and legible mark 
identifying the exporting country. Acceptable means of permanent 
identification include the following:
    (i) A mark properly applied with a freeze brand, hot iron, or other 
method, and easily visible on the live animal and on the carcass before 
skinning. Such a mark must be not less than 2 inches nor more than 3 
inches high, and must be applied to each animal's right hip, high on 
the tail-head (over the junction of the sacral and first cocygeal 
vertebrae). Bovines exported from Canada so marked must be marked with 
``C[and]N'';
    (ii) A tattoo with letters identifying the exporting country must 
be applied to the inside of one ear of the animal. For bovines exported 
from Canada, the tattoo must read ``CAN'';
    (iii) Other means of permanent identification upon request if 
deemed adequate by the Administrator to humanely identify the animal in 
a distinct and legible way as having been imported from the BSE 
minimal-risk exporting region.
    (3) Each bovine must be individually identified by an official 
eartag of the country of origin, applied before the animal's arrival at 
the port of entry into the United States, that is determined by the 
Administrator to meet standards equivalent to those for official 
eartags in Sec.  71.1 of this chapter and to be traceable to the 
premises of origin of the animal. No person may alter, deface, remove, 
or otherwise tamper with the official identification while the animal 
is in the United States or moving into or through the United States, 
except that the identification may be removed at the time of slaughter;
    (4) The bovines must be accompanied by a certificate issued in 
accordance with Sec.  93.405 that states, in addition to the statements 
required by Sec.  93.405, that the conditions of paragraphs (a)(1) and 
(a)(2) of this section have been met; and
    (5) The bovines must be imported only through a port of entry 
listed in Sec.  93.403(b) or as provided for in Sec.  93.403(f).
* * * * *

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL 
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL 
SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND 
RESTRICTED IMPORTATIONS

0
6. The authority citation for part 94 continues to read as follows:

    Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 
U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.


Sec.  94.19  [Amended]

0
7. Section 94.19 is amended as follows:
0
a. By removing the words ``and small intestine'' each time they appear 
in paragraphs (a)(2), (b)(2), and (f).
0
b. By removing the Note to paragraph (a).
0
c. By removing the Note to paragraph (b).
0
d. By removing the Note to paragraph (f).

PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), 
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES

0
8. The authority citation for part 95 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 
9701; 7 CFR 2.22, 2.80, and 371.4.


0
9. Section 95.4 is amended as follows:
0
a. The section heading and paragraph (a) introductory text are revised 
to read as set forth below.
0
b. Paragraphs (a)(1)(ii) and (a)(1)(iv) are revised to read as set 
forth below.
0
c. In paragraph (b), the words ``paragraphs (d) and (h)'' are removed 
and the words ``paragraphs (d), (e), and (i)'' are added in their 
place.
0
d. Paragraph (d) introductory text is revised to read as set forth 
below.
0
e. The ``Note to paragraph (f)'' and the ``Note to paragraph (g)'' are 
removed.
0
f. Paragraphs (e) through (h) are redesignated as paragraphs (f) 
through (i), respectively.
0
g. The ``Note'' currently following newly redesignated paragraph (f) is 
redesignated as ``Note to paragraph (f)''.
0
h. New paragraph (e) is added to read as set forth below.
0
i. In newly redesignated paragraph (h)(1)(i), the words ``and small 
intestine'' are removed.
0
j. In newly redesignated paragraph (i) introductory text, the words 
``paragraphs (h)(1) through (h)(3)'' are removed and the words 
``paragraphs (i)(1) through (i)(3)'' are added in their place, and the 
words ``paragraphs (h)(1) through (h)(4)'' are removed and the words 
``paragraphs (i)(1) through (i)(4)'' are added in their place.
0
k. In newly redesignated paragraph (i)(4)(iii), the reference to 
``paragraph (h)(2)'' is removed and a reference to ``paragraph (i)(1)'' 
is added in its place.


Sec.  95.4  Restrictions on the importation of processed animal 
protein, offal, tankage, fat, glands, certain tallow other than tallow 
derivatives, and blood and blood products due to bovine spongiform 
encephalopathy.

    (a) Except as provided in paragraphs (c) through (i) of this 
section, the importation of the following is prohibited:
    (1) * * *
    (ii) Glands, unprocessed fat tissue, and blood and blood products 
derived from ruminants;
* * * * *
    (iv) Derivatives of glands and blood and blood products derived 
from ruminants.
* * * * *
    (d) Except as provided in paragraph (e) of this section, the 
importation of serum albumin, serocolostrum, amniotic liquids or 
extracts, and placental liquids derived from ruminants that have been 
in any region listed in Sec.  94.18(a) of this chapter, and collagen 
and collagen products that meet any of the conditions listed in 
paragraphs (a)(1) through (a)(3) of this section, is prohibited unless 
the following conditions have been met:
* * * * *
    (e) Bovine blood and blood products that are otherwise prohibited 
importation under paragraph (a)(1) or (d) of this section may be 
imported into the United States if they meet the following conditions:
    (1) For blood collected at slaughter and for products derived from 
blood collected at slaughter:
    (i) The blood was collected in a closed system in which the blood 
was conveyed directly from the animal in a closed conduit to a closed 
receptacle, or was collected otherwise in a hygienic manner that 
prevents contamination of the blood with SRMs.
    (ii) The slaughtered animal passed ante-mortem inspection and was 
not subjected to a pithing process or to a stunning process with a 
device injecting compressed air or gas into the cranial cavity;
    (2) For fetal bovine serum:
    (i) The blood from which the fetal bovine serum was derived was 
collected in a closed system in which the blood was conveyed directly 
from the animal in a closed conduit to a closed

[[Page 53379]]

receptacle, or was collected otherwise in a hygienic manner that 
prevents contamination of the blood with SRMs;
    (ii) The dam of the fetal calf passed ante-mortem inspection and 
was not subjected to a pithing process or to a stunning process with a 
device injecting compressed air or gas into the cranial cavity;
    (iii) The uterus was removed from the dam's abdominal cavity intact 
and taken to a separate area sufficiently removed from the slaughtering 
area of the facility to ensure that the fetal blood was not 
contaminated with SRMs when collected.
    (3) For blood collected from live donor bovines and for products 
derived from blood collected from live donor bovines:
    (i) The blood was collected in a closed system in which the blood 
was conveyed directly from the animal in a closed conduit to a closed 
receptacle, or was collected otherwise in a hygienic manner that 
prevents contamination of the blood with SRMs;
    (ii) The donor animal was free of clinical signs of disease.
    (4) Each shipment to the United States is accompanied by an 
original certificate signed by a full-time salaried veterinary officer 
of the national government of the region of origin, or issued by a 
veterinarian designated by or accredited by the national government of 
the region of origin, representing that the veterinarian issuing the 
certificate was authorized to do so. The certificate must state that 
the requirements of paragraph (e)(1), (e)(2), or (e)(3) of this 
section, as applicable, have been met.
* * * * *

PART 96--RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS 
OFFERED FOR ENTRY INTO THE UNITED STATES

0
10. The authority citation for part 96 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 7 CFR 
2.22, 2.80, and 371.4.


0
11. In Sec.  96.1, definitions of Food and Drug Administration and Food 
Safety and Inspection Service are added, in alphabetical order, to read 
as follows:


Sec.  96.1  Definitions.

* * * * *
    Food and Drug Administration. The Food and Drug Administration of 
the United States Department of Health and Human Services.
    Food Safety and Inspection Service. The Food Safety and Inspection 
Service of the United States Department of Agriculture.
* * * * *


0
12. In Sec.  96.2, paragraph (b) is revised to read as follows:


Sec.  96.2  Prohibition of casings due to African swine fever and 
bovine spongiform encephalopathy.

* * * * *
    (b) Ruminant casings. The importation of casings, except stomachs, 
from ruminants that originated in or were processed in any region 
listed in Sec.  94.18(a) of this subchapter is prohibited, except as 
provided in paragraphs (b)(1) and (b)(2) of this section:
    (1) Casings that are derived from sheep that were slaughtered in a 
region listed in Sec.  94.18(a)(3) of this subchapter at less than 12 
months of age and that were from a flock subject to a ruminant feed ban 
equivalent to the requirements established by the U.S. Food and Drug 
Administration at 21 CFR 589.2000 may be imported.
    (2) Casings that are derived from bovines that were slaughtered in 
a region listed in Sec.  94.18(a)(3) of this subchapter may be 
imported, provided, if the casings are derived from the small 
intestine, the casings are derived from that part of the small 
intestine that is eligible for use as human food in accordance with the 
requirements established by the Food Safety and Inspection Service at 9 
CFR 310.22 and the Food and Drug Administration at 21 CFR 189.5.
    (3) Casings imported in accordance with either paragraph (b)(1) or 
(b)(2) of this section must be accompanied by a certificate that:
    (i) States that the casings meet the conditions of this section;
    (ii) Is written in English;
    (iii) Is signed by an individual eligible to issue the certificate 
required under Sec.  96.3; and
    (iv) Is presented to an authorized inspector at the port of entry.
* * * * *

0
13. In Sec.  96.3, paragraph (d) is revised to read as follows:


Sec.  96.3  Certificate for animal casings.

* * * * *
    (d) In addition to meeting the requirements of this section, the 
certificate accompanying sheep casings from a region listed in Sec.  
94.18(a)(3) of this subchapter must state that the casings meet the 
requirements of Sec.  96.2(b)(1), and the certificate accompanying 
bovine casings from a region listed in Sec.  94.18(a)(3) of this 
subchapter must state that the casings meet the requirements of Sec.  
96.2(b)(2).
* * * * *

    Done in Washington, DC, this 12th day of September 2007.
Charles D. Lambert,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 07-4595 Filed 9-14-07; 8:45 am]
BILLING CODE 3410-34-P